A multicenter prospective observational study appraising the effectiveness of the Supera stent after subintimal recanalization of femoro-popliteal artery occlusion: The SUPERSUB II study.

BACKGROUND: Complex femoropopliteal artery disease represents a challenge. The Supera stent holds the promise of improving the results of endovascular therapy for complex femoropopliteal disease. AIMS: We aimed at appraising the early and long-term effectiveness of the Supera stent after successful subintimal angioplasty (SuperSUB strategy) for complex femoropopliteal lesions. METHODS: We conducted a multicenter, prospective, single-arm observational study including consecutive patients at participating centers in whom Supera was implanted after successful subintimal angioplasty for complex femoropopliteal lesions. RESULTS: A total of 92 patients were included Femoropopliteal arteries were the most common target, and lesion length was 261 ± 102 mm. Most procedures were technically demanding, with antegrade femoral access in 35 (38%) and retrograde distal access in 55 (60%). Supera stent length was 281 ± 111 mm, with 4, 5, and 6 mm devices being most commonly used: 32 (35%), 35 (38%), and 23 (25%), respectively. Technical success was achieved in 100% of subjects, as was clinical success (per subject), whereas procedural success (per subject) was obtained in 98%. At 24 months, freedom from clinically driven target lesion revascularization was 93%, whereas primary patency was 87%. When compared with a similar historical cohort, Supera stent use appeared to be associated with a reduction in resources. CONCLUSION: Use of Supera stent after successful subintimal recanalization of complex lower limb arterial lesions yields favorable procedural results, which are maintained over follow-up, and are associated also with a favorable resource use profile.

Endovascular treatment with interwoven nitinol stent for common femoral artery lesions: 2-year outcomes of a single center experience.

OBJECTIVE: The study aimed was to report 2-year outcomes of endovascular treatment with interwoven nitinol (Supera™) stent for common femoral artery (CFA) lesions. METHODS: We reviewed the clinical data of 20 patients who presented with CFA stenosis or occlusion and underwent balloon angioplasty followed by Supera™ stenting in CFA between February 2016 and January 2022. The outcomes were evaluated in these patients in terms of technical success, post-intervention complications, reintervention, and cumulative patency (1 year, and 2 years). RESULTS: The study included 20 patients (22 lesions) who presented with isolated CFA lesions (3), iliac lesions involving CFA (6), superficial femoral artery (SFA) lesions involving CFA (8), and extensive lesions from the iliac artery to SFA (5). There were 16 men (80%) with a mean age of 69.7 years (range, 34-83). Hypertension, smoking, and diabetes were found in 15 (75%), 7 (35%), and 7 patients (35%), respectively. Clinical presentations were Rutherford stage 5 (9, 45%), Rutherford stage 4 (5, 25%), Rutherford stage 6 (4, 20%), and Rutherford stage 3 (2, 10%). Technical success was achieved in all patients (100%). The procedures for treatment were isolated CFA Supera™ stenting (1, 4.5%), CFA plus DFA Supera™ stenting (jailed SFA) (2, 9.1%), CFA plus SFA Supera™ stenting (jailed DFA) (8, 36.4%), CFA Supera™ stenting plus bare iliac stenting (Astron) (6, 27.3%), CFA plus SFA Supera™ stenting (jailed DFA) plus bare iliac stenting (Astron) (5, 22.7%), and additional DFA angioplasty (7, 31.8%). The rate of in-hospital mortality and morbidity were 0% and 10%, respectively. Distal embolization after pre-dilatation occurred in 1 patient, and cerebral infarction occurred 12 h after the procedure in 1 patient. The mean follow-up time was 23 months (range, 2-64). During the follow-up period, in-stent occlusion occurred in 2 patients at 9 and 46 months. Re-intervention was performed in 1 patient due to recurrent symptom of claudication. The cumulative primary patency at 1 year and 2 years were 93.3% and 93.3%, respectively. CONCLUSION: Endovascular treatment with interwoven nitinol (Supera™) stent for CFA lesions was associated with acceptable outcomes at 2 years.

IVUS Improves Outcomes With SUPERA Stents for the Treatment of Superficial Femoral-Popliteal Artery Disease.

BACKGROUND: Nitinol interwoven bare metal stents represent an advancement in stent technology; however, nominal deployment remains an area of focus. Intravascular ultrasound (IVUS) has been shown to improve outcomes in both the coronary and peripheral vasculature by providing the operator with greater vessel detail; however, the use of adjunctive IVUS with nitinol bare metal stents has not been widely studied. This studies aims to determine the effect of IVUS when used adjunctively with nitinol interwoven bare metal stents in the management of femoropopliteal lesions. DESIGN: Retrospective study. METHODS: This study included a cohort of 200 consecutive patients with peripheral artery disease. All patients were treated with ≥1 Supera bare metal stent, and 91 received adjunctive IVUS imaging prior to stent deployment. Deployment conditions of nominal, compressed, and elongated were measured, and the primary clinical outcomes included target lesion reintervention, amputation, and mortality. This study also showed that 8.3 number needed to treat (NNT) patients must be treated with IVUS to avoid an additional revascularization event. RESULTS: The patients who received IVUS had a significantly greater number of nominally deployed stents (p<0.001). Patients who had IVUS imaging also had significantly lower reintervention rates compared with those who did not receive IVUS imaging (p=0.047). CONCLUSION: The IVUS and angiography decreases clinically-driven target lesion reintervention and increases nominal deployment compared with angiography alone in femoropopliteal lesions treated with interwoven bare metal nitinol stents. CLINICAL IMPACT: Endovascular surgones may conisder the adjuctive use of IVUS when using the Supera stent for the treatment of infra inguinal superficial femoral artery lesions. The adjunct use of IVUS may lead to improved sizing, vessel prep, deployment, and ultiamtely reduction in CD-TLR.

Treatment of Long Femoropopliteal Lesions With Self-Expanding Interwoven Nitinol Stent: 24 Month Outcomes of the STELLA-SUPERA Trial.

PURPOSE: The performance of self-expanding interwoven nitinol stent (Supera) in femoropopliteal interventions has been proven through trials with short lesions and with relatively low proportion of occlusions. There is limited evidence of Supera stent in long lesions. The aim of this study was to assess the clinical safety and efficiency of the Supera stent in the treatment of long femoropopliteal lesions (Trans-Atlantic Inter-Society Consensus [TASC] C/D) in patients with symptomatic peripheral arterial disease (PAD). METHODS: The STELLA SUPERA (STEnting Long de L'Artère fémorale superficielle par le stent métallique Supera) is a prospective, 2-center, single-arm study. Patients with symptomatic (Rutherford stages 2-6) de novo and TASC C/D lesions of the femoropopliteal segment were treated with Supera stent. The primary endpoint was the primary sustained clinical improvement at 12 months. Follow-up included clinical examination, duplex scan, and biplane X-ray up to 24 months. RESULTS: Between December 2016 and October 2018, 48 symptomatic patients with 49 femoropopliteal lesions (TASC D = 32, 65%) were treated. The mean lesion length was 234 ± 123 mm, and 78% were total occlusion. The mean stented lesion length was 273 ± 127 mm. At 12 and 24 months, the primary sustained clinical improvement rate was 87.2% and 79.7%, respectively. The Rutherford category assessment was significantly improved at 24 months compared with baseline (p=0.02). At 24 months, the primary patency and freedom from target lesion revascularization (TLR) rates were 77.9% and 86.9%, respectively. The ankle-brachial pressure index increased from 0.62 ± 0.15 at baseline to 0.93 ± 0.15 at 24 months (p<0.0001). There were no stent fractures at 24 months. CONCLUSION: The use of Supera stent in long lesions (TASC C/D) is a safe and effective endovascular alternative. These results reinforce the need for randomized clinical trials to assess the value of interwoven stents for long femoropopliteal lesions.

Treatment of Long Femoropopliteal Occlusive Lesions With Self-expanding Interwoven Nitinol Stent: 24 Month Outcomes of the STELLA-SUPERA-SIBERIA Register Trial.

PURPOSE: The efficacy and safety of the Supera stent in superficial femoral artery (SFA) have been reported mostly in shorter lesions with relatively low proportion of occlusions. There are little data on the effectiveness of the Supera stent in long lesions. The aim of this study was to assess the clinical safety and efficiency of the Supera stent in the treatment of long femoropopliteal occlusive lesions (Trans-Atlantic Inter-Society Consensus [TASC] C/D) in patients with symptomatic peripheral artery disease. MATERIALS AND METHODS: The STELLA-SUPERA-SIBERIA is a prospective, single-center, single-arm study. Patients with symptomatic (Rutherford stages 3-6) de novo and TASC C/D occlusive lesions of the femoropopliteal segment were treated with Supera stent. The primary endpoint was the 12 month rate of primary sustained clinical improvement (upward shift on the Rutherford classification to a one level without the need for repeated target lesion revascularization (TLR) in surviving patients without the need for unplanned amputation). Secondary endpoints were the 24 month of primary sustained clinical improvement, MALE, limb salvage, the primary patency, the secondary patency, 24 month MACE. Follow-up included clinical examination, duplex scan, and biplane x-ray up to 24 months. RESULTS: Between April 2019 and January 2020, 52 symptomatic patients with 55 long femoropopliteal occlusive lesions (52.7% TASC D lesions and 47.3% TASC C lesions) were treated. The mean target lesion length was 205±72 mm. All patients had total occlusions. The mean lesion length of the implanted Supera stents was 198±82 mm. At 12 and 24 months, the primary sustained clinical improvement rate was 80.2% and 63.6%, respectively. The Rutherford category assessment was significantly improved at 24 months compared with baseline (p=0.02). The primary patency rate at 12 and 24 months was 78.1% and 60.0%, respectively. At 12 and 24 months, freedom from TLR was 83.5% and 81.8%, respectively. There were no stent fractures at 24 months. CONCLUSION: Supera Stent implantation for TASC C/D femoropopliteal lesions revascularization appears to be a safe and efficient implant given the complexity of the treated lesions. Head-to-head studies are mandatory to establish Supera Stent as an alternative tool to open surgery for long femoropopliteal lesions. CLINICAL IMPACT: Our study indicated, that using self-expanding interwoven nitinol stent for TASC C/D femoropopliteal lesions revascularization appears to be a safe and efficient implant given the complexity of the treated lesions. Although bypass grafting is recommended for prolonged femoropopliteal lesions, open surgery is more traumatic and is associated with greater risks than endovascular procedures. Our findings suggest that the use of interwoven nitinol stents can overcome the disadvantages of traditional stents in such cases, which may help to improve patients' outcomes and reduce the risk of adverse events.

Directional Atherectomy With Antirestenotic Therapy Versus PTA/Supera Stenting for Popliteal Artery Lesions: A Propensity-Matched Analysis.

PURPOSE: This study examines the use and impact of directional atherectomy with antirestenotic therapy (DAART) versus angioplasty plus Supera stent implantation on the outcomes during endovascular treatment of popliteal lesions in clinical practice. METHODS: Overall 143 consecutive patients (mean age 75.0±12.2 years, 72% male), with isolated atherosclerotic disease of the popliteal artery who underwent endovascular treatment using DAART therapy or percutaneous transluminal angioplasty (PTA)/Supera stenting of the popliteal artery between January 2016 and December 2021 were identified from a retrospectively database. Patient and plaque characteristics were collected. A propensity-score matched, case-control analysis was conducted to balance covariates between the group of patients who underwent DAART and the one treated by PTA/Supera stenting. RESULTS: A total of 51 patients (35.7%) showed severe claudication and 92 (64.3%) critical limb ischemia. There was a trend toward longer treated lesions (90.4±81 vs 72.5±5.3 mm, p=0.089) and more chronic total occlusions (60.5% vs 46.8%, p=0.058) in the PTA/Supera stenting group, although not reaching statistically significance. Moderate-to-severe calcification was present in most lesions treated (75.8% of DAART group, 80.2% of PTA/Supera stenting group, and 78.3% of total cohort). Among the 53 case-matched pairs of patients treated with DAART or PTA/Supera stenting, there were no significant differences in short-term outcomes, including rate of technical success (96.2% vs 98.1%, p=0.232), procedural success (88.7% vs 90.1%, p=0.251), distal embolization (1.9% vs 1.9%, p=0.178), dissection (5.7% vs 1.9%, p=0.268), perforation (3.8% vs 5.6%, p=0.163), hospital discharge (1.2±0.1 vs 1.0±0.1, p=0.325), 30 day minor (28.3% vs 32.1%, p=0.264) or major amputation rates (7.5% vs 3.8%, p=0.107), and 30 day mortality (1.9% vs 1.9%, p=0.173). At 1 year, there was no difference in primary patency (73.6% vs 77.4%, p=0.233), primary assisted patency (81.3% vs 84.9%, p=0.167), secondary patency (86.8% vs 92.5%, p=0.094), ipsilateral minor (35.8% vs 39.6%, p=0.472) or major amputation (9.4% vs 7.5%, p=0.186), ankle brachial index improvement (0.32±0.12 vs 0.37±0.37, p=0.401), or mortality (5.7% vs 5.7%, p=0.121) rate between patients who underwent DAART or PTA/Supera stenting for popliteal lesions. CONCLUSION: Twelve-month results following DAART technique or PTA/Supera stenting of atherosclerotic lesions of the popliteal artery are not different, regardless of patient and plaque characteristics. CLINICAL IMPACT: The DAART technique for the treatment of popliteal artery atherosclerotic disease is presented as a "leave nothing behind" strategy with on-year clinical outcomes similar to ATP/Supera stenting.

Five-Year Experience of Interwoven Self-Expanding Stent Implantation in Stenotic Kinking of Below the Knee Prosthetic Bypasses.

PURPOSE: The purpose of this study was to evaluate the 5-year real-world results of Supera stent implantation in below the knee prosthetic bypasses (BKPBs). All the procedures were performed because of a history of recurrent thrombosis of the graft and significant stenotic kinking of the prosthesis during knee flexion. A Supera stent was implanted to prevent the next potential BKPB thrombosis. MATERIALS AND METHODS: Fourteen patients were included in this single-center, retrospective observational cohort study. All patients underwent Supera stent implantation in infrainguinal prosthetic bypass between 2012 and 2017, due to a history of recurrent thrombosis and kinking of the prosthetic bypass. RESULTS: Prior to Supera stent implantation procedure, all the patients had more than one episode of acute limb ischemia caused by thrombosis of the BKPB. The median number of BKPB thromboses prior to Supera stent implantation was 3 and ranged from 2 to 6. Technical success was achieved in all cases. Primary patency rates at 12, 24, 36 and 60 months were 71.4%, 57.1%, 57.1% and 14.3%, respectively. Secondary patency rates at 12, 24, 36 and 60 months were 78.6%, 64.3%, 64.3% and 35.7%, respectively. One stent fracture was reported during 60-month follow-up. Major amputation was performed in 6 patients in 5-year follow-up. CONCLUSION: Supera stent in treatment of recurrent thrombosis of BKBP is a safe procedure with acceptable mid-term results. However, larger and comparable prospective studies are needed for broader analysis of this procedure.

Pure Endovascular versus Hybrid Approach for Management of Iliofemoral Arterial Disease: A Randomized Controlled Trial.

Common femoral artery (CFA) atherosclerotic lesions currently remain one of the last limitations for adoption of endovascular repair as the first-line treatment, easy surgical accessibility, and, last but not least, favorable long-term outcomes, still making CFA disease treatment part of the surgical domain. In the last 5 years, improvement of the endovascular equipment and technical skills of the operators have led to an increase in percutaneous CFA procedures. A single-center randomized prospective study of 36 symptomatic (Rutherford 2-4) CFA stenotic or occlusive lesions were included, and patients were randomized over two groups based on the management approach SUPERA versus hybrid technique. Patients had a mean age 60.8 ± 8.2 years. Thirty-two (88.9%) patients reported improvement of the clinical symptoms, 28 (87.5%) patients had intact pulse postoperatively, and 28 (87.5%) had patent vessels. Follow-up showed that none developed reocclusion or restenosis during the period of follow-up. Comparison of difference in peak systolic velocity ratio (PSVR) among study groups showed that the hybrid technique had more reduction of PSVR postintervention compared to the SUPERA group with a p -value of < 0.0001. Safety and feasibility of endovascular approach with the SUPERA stent to the CFA (no stent zone) has low incidence of postoperative morbidity and mortality in well experienced surgical hands.

SUPERA stent placement for salvaging early recurrent arteriovenous graft thrombosis after percutaneous transluminal angioplasty: A single-center study.

BACKGROUND: The aim of this study was to evaluate the patency of the helical interwoven SUPERA stent for salvaging prosthetic arteriovenous (AV) grafts with rapidly recurrent thrombotic occlusion developed within a short time period after successful percutaneous transluminal angioplasty. METHODS: From December 2019 to September 2021, the data of 20 patients with AV graft who had the SUPERA stent inserted satisfying the following conditions were consecutively collected. (1) More than 1 year has passed since the AV access operation; (2) Thrombotic re-occlusion of AV graft occurred within 3 months after previous successful endovascular treatment; (3) Residual stenosis is greater than 30% after full effacement of balloon angioplasty in the primary lesion. Post-interventional target lesion primary patency (TLPP), access circuit primary patency (ACPP), and secondary patency (SP) were calculated. RESULTS: Primary lesions of early recurrent arteriovenous graft thrombosis were found in 13 patients with graft-vein anastomosis, six patients with intra-graft stenosis, and one patient with outflow vein complications. The lesions showed residual stenosis in 47.4% (interquartile range: 44.1%-55.3%) of patients despite full-effacement balloon angioplasty. Clinical success was achieved in all patients with full-expansion of the stents at the 1-month follow-up. The TLPP was 70.7% and 32% at 6 and 12 months, respectively, and ACPP was 47.5% and 6.8% at 6 and 12 months, respectively. The SP was 76.1% and 57.1% at 6 and 12 months, respectively. No cannulation complications occurred in the six patients with installation inside the graft. No hemodialysis or stent fracture occurred in any patient during the follow-up period. CONCLUSIONS: The SUPERA stent may have a role in salvaging AV grafts with early recurrent thrombosis due to its greater radial force and its conformability and can be useful in treating stenosis involving the elbow or axilla, with fair patency and low complication rates.

Sheathless use of Supera stent minimizes access complications in antegrade femoral puncture: Technical note with case series.

Antegrade femoral puncture (AFP) is the preferred strategy to treat lower limb obstructive disease. However, the presence of vascular calcification may be associated with procedure related adverse events, impairing endovascular device strategies. We describe a case series of superficial femoral and popliteal artery treatments by Supera stent implantation using a simple technique to significantly minimize the dimension of the antegrade femoral puncture from 6 to 4 French (Fr). All antegrade femoral punctures, crossing femoro-popliteal lesion and predilation were made with 4 Fr introducer. After preparation the Supera stent was navigated in sheathless fashion via 0.018-inch guidewire. Postdilation and final control were made replacing the 4 Fr introducer via the same guidewire. A good final result was achieved. Patients were discharged early without any complications. This minimally invasive technique in cases of infrainguinal peripheral artery disease could be feasible and effective for minimizing the risk of complications in patients with critical limb ischemia.

Three-Year Real-World Outcomes of Interwoven Nitinol Supera Stent Implantation in Long and Complex Femoropopliteal Lesions.

BACKGROUND: Peripheral artery disease (PAD) remains a major issue in modern societies and affects more than 200 million people around the world. Endovascular methods have been evaluated to be safe and effective in limb salvage. The Supera is able to withstand increased compression, biomechanical stress and to have higher radial force. The objective of this study is to evaluate performance, durability and 3-year patency of Supera stent implantation in severe femoropopliteal disease. METHODS: A retrospective real-world analysis was performed with consideration of 77 patients that had a Supera stent implanted with femoropopliteal atherosclerotic disease at a single center. Among the 77 individuals, 92 Supera stents were implanted. Analysis of patients' demographics, lesions characteristics, reintervention rates and patency rates was performed. RESULTS: The median follow-up was 33 months and ranged from 0 to 84 months. Chronic limb-threatening ischemia was observed among 43 patients. Mean lesion length was 152.8 ± 94.6 mm. Chronic total occlusions were observed in a majority of lesions. Overall, primary patency rates at 6, 12, 24 and 36 months were 85.0%, 73.6%, 59.2% and 53.2%, respectively. CONCLUSIONS: The Supera stent is effective in the management of long and complex lesions. The results of patency rates were evaluated to be worse among lesions extending to the popliteal artery.

Supera stent implantation for the treatment of isolated popliteal artery disease systematic review and evaluation of current endovascular strategies.

<b>Introduction:</b> The anatomical location of the popliteal artery is one of the greatest challenges for percutaneous interventions. The biomechanical attributes of the vessel lead to higher rates of restenosis, stent fracture, and occlusion. Some surgeons consider the popliteal artery as a no stenting zone. Many specialists favor percutaneous transluminal angioplasty to be the first line of endovascular treatment in the popliteal artery with bail-out stent implantation if the results are suboptimal. The Supera peripheral stent system is a novel stent that has been manufactured with a high degree of flexibility and supposedly might be appropriate for implantation in the popliteal artery. </br></br> <b>Aim:</b> Evaluation of the performance of Supera stent in isolated popliteal artery disease in comparison to other methods of treatment. </br></br> <b>Methods:</b> As many as 92 articles were found in the databases and after full-text review, 4 studies matched the inclusion criteria and were evaluated. </br></br> <b>Results:</b> Primary patency rates of Supera implantation in an isolated popliteal artery at 12 months ranged from 68% to 90%. In all four studies, no stent fractures were observed. Only one study provided longer follow-up than 12 months and evaluated the performance of the Supera stent 36 months after implantation. </br></br> <b>Conclusion:</b> In conclusion, mentioned studies show promising and superior to other stent patency rates of the Supera stent regarding popliteal artery lesions. What is more, no stent fracture is promising regarding longer follow-up. However, more studies with longer follow-ups and direct comparison to other methods are required to fully evaluate Supera's performance in the popliteal artery.

Superficial Femoral Artery Rupture "Bailed Out" Using Novel Design of Supera Stent.

Peripheral artery disease is a condition that occurs due to narrowing or occlusion of arterial lumen usually secondary to atherosclerosis. Endovascular treatments are minimally invasive procedures that have become popular for recanalization of such calcified/sclerosed arteries. However, heavily calcified arteries make these procedures challenging and are more prone to complications like balloon rupture and bleeding. Herein, we report a novel case of rupture of superficial femoral artery and its management using self-expanding Supera stent.

Analysis of Interwoven Nitinol Stenting for the Treatment of Critical Limb Ischemia: Outcomes From an Average 3-Year Follow-up Period.

We assessed the clinical outcomes of patients with critical limb-threatening ischemia (CLTI) who underwent interwoven nitinol stent (Supera) implantation for significant stenoses of the femoropopliteal segment. In this retrospective cohort study, 116 consecutive patients with CLTI who were treated with Supera stents between September 2015 and March 2020 were included in this analysis. Primary endpoint analysis was completed for amputation-free survival, target lesion revascularization (TLR), and mortality. After a mean follow-up time of 3.4 years, 21 (18%) patients had undergone amputations, 3 (2.6%) died, and, overall, the amputation-free survival rate was 81%. TLR occurred in 21 (18%) patients, resulting in the freedom from target lesion revascularization of 82%. The average Wagner score for all patients was 2.8 ± 1.1. A subgroup analysis of 57 patients revealed a median ulcer size of 3.0 cm2 [1.65, 9.0], with complete healing for 45 patients by 20 months. The Wagner score of this subgroup decreased by an average of 3.4 ± .9 points. Supera stents can be used together with other endovascular therapies and are a safe and effective treatment modality for CLTI.

Endovascular retrieval of an elongated Supera stent.

Stenting is used to achieve artery patency, and the Supera stent, a self-expanding interwoven nitinol stent, has produced good clinical outcomes. A 70-year-old woman with peripheral artery disease had experienced intermittent claudication (Fontaine stage IIb). Endovascular treatment was performed for a chronic total occlusion TransAtlantic InterSociety Consensus class II type B lesion. A Supera stent (Abbott Vascular, Santa Clara, CA) was used. However, it had become severely elongated to the proximal end in the superficial femoral artery and was removed using a balloon inserted from the side and trapped to the guide sheath with the distal end of the stent outside the sheath. After this bailout, an alternate stent could be placed through an antegrade approach to the contralateral common femoral artery.

Helical stent (SUPERA™) and drug-coated balloon (Passeo-18 Lux™) for recurrent cephalic arch stenosis: Rationale and design of arch V SUPERA-LUX Study.

BACKGROUND: The treatment options for cephalic arch stenosis are limited and standard of care remains at crossroads - none are ideal and there is currently no gold standard. Endovascular techniques are now the preferred primary therapeutic option because they are minimally invasive and better tolerated by haemodialysis patients who have multiple comorbidities. However, conventional plain old balloon angioplasty, bare metal stenting and stent grafts all have their limitations. The aim of this trial is to evaluate whether the helical SUPERA™ stent (Abbott Vascular, Santa Clara, CA, USA), which has a higher degree of flexibility and resistance to compressive forces compared to traditionally laser-cut nitinol stents, combined with a drug-coated balloon (Biotronik Passeo-18 Lux™) to minimize the neointimal hyperplasia effect, can improve patency and reduce reintervention rates. METHODS AND RESULTS: Arch V SUPERA-LUX is a pilot investigator-initiated single-centre, single-arm prospective study. Twenty patients with a brachiocephalic fistula within 6 months of initial plain old balloon angioplasty for significant cephalic arch stenosis will be recruited for treatment with SUPERA and drug-coated balloon. The primary objectives are immediate angiographic and procedural success, primary patency and functional fistula at 1 week, 8 weeks, 6 and 12 months. The results from eight patients treated prospectively as proof of concept have shown primary patency of 83.3% at 1 year with 100% technical and procedural success rates. Enrolment for the Arch V SUPERA-LUX study is expected to be completed at the end of 2019. CONCLUSION: The Arch V SUPERA-LUX study is the first trial to evaluate whether SUPERA stent implantation and drug-coated balloon use can provide superior protection against restenosis compared to traditional angioplasty, bare metal stents and stent grafts in recurrent cephalic arch stenosis. Initial pilot results are encouraging but longer follow-up is required to truly test this technique. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov NCT03891693.

Early Supera stent fracture in the femoropopliteal artery.

The Supera peripheral stent has been designed to resist stent fracture, which can develop from the torsion and compressive forces in the femoropopliteal artery. We report on a case of Supera peripheral stent fracture in the early period after the index procedure in a patient with femoropopliteal artery disease. An individualised approach, considering the lesion location, patient's age and exercise capacity is important for the treatment of femoropopliteal artery disease.

Endovascular Treatment of Simultaneous Iliac and Superficial Femoral Arterial Pseudoaneurysms After Stenting Procedure Complications.

PURPOSE:: To report on the endovascular management of a patient affected by concomitant left common iliac artery and right superficial femoral artery (SFA) pseudoaneurysms after stent positioning. CASE REPORT:: A 77-year-old man affected by severe lower limb atherosclerosis was previously treated with iliac and femoropopliteal Supera stenting procedures; he presented to our emergency department because of bilateral severe claudication recurrence, back pain, and right groin region swelling. Angio-computed tomography (CT) depicted 2 pseudoaneurysms of the left common iliac artery and right SFA, due to stent fracture and stent intussusception, respectively. A 2-step endovascular treatment was planned using bilaterally covered stent-grafts to exclude vascular lesions from blood flow. The devices were successfully deployed without any complication. At 1 month, angio-CT confirmed patency of the implanted stent-grafts showing complete pseudoaneurysm exclusion without leaks. CONCLUSION:: Endovascular approach can be a valid option in the treatment of pseudoaneurysms due to stenting procedure complications.

Newly approved devices for endovascular treatment of femoropopliteal disease: a review of clinical evidence.

Introduction: Femoropopliteal lesions account for a significant proportion of endovascular interventions for peripheral artery disease. In this manuscript, we review the literature on the application of newly approved devices in the treatment of atherosclerotic lesions at this segment.Areas covered: New drug-coating technologies provide sustained drug-eluting over time and better scaffolds are more resistant to the increased biomechanical stress at the femoropopliteal segment. Thus, the newer drug-eluting stents (i.e. Eluvia®), nitinol interwoven stents (i.e. Supera®), and drug-coated balloons (i.e. Stellarex®) are associated with improved pharmacokinetic profiles and promising primary patency rates. A major predictor of technical failure and restenosis is the calcification of the target vessel. Recently, intravascular lithotripsy of calcified lesions at the femoropopliteal segment with the Shockwave® balloon was introduced as a feasible treatment option for these complex lesions. Finally, we also describe the Tack Endovascular System®, the first-of-its-type, for the repair of post-angioplasty dissections.Expert opinion: The use of innovative stent designs and novel drug-coating, the application of adjunctive intravascular lithotripsy, and the combined use of new devices treating complications might improve the overall outcomes of angioplasty, thereby promising favorable outcomes even for more complex lesions.

SUPERA stent outcomes in Above-The-Knee IntervEntions: Effects of COMPression and ELongation (SAKE-COMPEL) Sub-study.

INTRODUCTION: The interwoven nitinol design of the Supera stent has been shown to have superior radial strength and fracture resistance resulting in higher patency rates at 6 and 12months. A detailed sub-analysis of SUPERB trial showed differences in patency based on stent conformation post deployment. We evaluated the patency of the stent within the SAKE study cohort based on stent deployment conformation. METHODS: We retrospectively evaluated the medical records of 63 patients (77 limbs) with Rutherford class 2-5 symptoms who received Supera stents in the femoro-popliteal artery from March 2010 through May 2011 as part of the SAKE study. These patients were followed for patency and the need for re-intervention over a mean follow up of 15months. Compression or Elongation was defined as follows based on previous sub-analyses: Moderate Compression (-40 to -21%); Minimal Compression (-20 to -11%); Nominal (-10 to 10%); Minimal Elongation (11 to 20%); Moderate Elongation (21 to 40%); and Severe Elongation (>40%). Significance was determined using Chi X2 test. RESULTS: The best patency rates (85.2% primary patency and 92.6% assisted primary patency) and lowest re-intervention rates (14.8%) were achieved with stent compression, followed by nominal deployment or minimal elongation, and worst outcomes (64.7% primary patency; 82.3% assisted primary patency; and 35.3% re-intervention) with stent elongation to moderate or severe degree. CONCLUSIONS: Patency rates and re-intervention rates are variable based on deployment characteristics of the Supera stent. Best outcomes are achieved with compression of the stent during deployment.