A Hybrid Approach That May Facilitate the Repair of Traumatic Popliteal Artery Pseudoaneurysms.

PURPOSE: Traumatic popliteal pseudoaneurysms may occur in accidents or as an iatrogenic complication of a total knee arthroplasty. Complications often arise in open repair because of distorted anatomy. Up to 22% of the patients may suffer above-knee amputation. Endovascular treatment has proven to be an effective solution. However, the long-term performance of stents at the hinge point of the popliteal artery is questionable. We present a hybrid technique that was used successfully in 2 cases. TECHNIQUE: Our approach takes advantage of both open and endovascular techniques. At first, we apply a stent graft at the side of the injury to cover the arterial trauma and stop blood leakage to the aneurysm sac. This allows for a safer dissection and open repair. We clamp the artery proximally and distally, open the sac, extract the stent graft, and extend to a longitudinal arteriotomy. We then reconstruct the entire area with a standard in lay end-to-end anastomosis using a vein graft. This hybrid technique may reduce the risk of uncontrollable bleeding and allow for a safer nerve decompression. CONCLUSIONS: Repair of such injuries is technically demanding. A hybrid approach may reduce the risk of complications and offer excellent long-term outcomes. CLINICAL IMPACT: The hybrid approach to the treatment of traumatic popliteal pseudoaneurysms combines the advantages of both open and endovascular approaches. It may be possible to make an acute operation just as safe as an elective operation by implementing the proposed strategy. The procedure can be performed by surgeons of all levels, and patients may benefit from a safer surgical dissection with fewer complications and blood loss. This smart combination of standard techniques may prove invaluable in a hostile surgical environment where limb loss is likely.

Outcomes of the Gore® Excluder® Iliac Branch Endoprosthesis Using Self Expanding or Balloon-Expandable Stent Grafts for the Internal Iliac Artery Component.

OBJECTIVE: The GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, Arizona) was developed to be used in combination with a self-expanding stent graft (SESG) for the internal iliac artery (IIA) bridging stent. Balloon-expandable stent grafts (BESGs) are an alternative for the IIA, offering advantages in sizing, device tracking, precision, and lower profile delivery. We compared the performance of SESG and BESG when used as the IIA bridging stent in patients undergoing EVAR with IBE. METHODS: This is a retrospective review of consecutive patients who underwent EVAR with IBE implantation at a single center from October 2016 to May 2021. Anatomic and procedural characteristics were recorded via chart review and computed tomography (CT) postprocessing software (Vitrea® v7.14). Devices were assigned to SESG vs. BESG groups based on the type of device landing into the most distal IIA segment. Analysis was performed per device to account for patients undergoing bilateral IBE. The primary endpoint was IIA patency, and secondary endpoint was IBE-related endoleak. RESULTS: During the study period, 48 IBE devices were implanted in 41 patients (mean age 71.1 years). All IBE devices were implanted in conjunction with an infrarenal endograft. There were 24 devices in each of the self-expanding internal iliac component (SE-IIC) and balloon-expandable internal iliac component (BE-IIC) groups. The BE-IIC group had smaller diameter IIA target vessels (11.6±2.0 mm vs. 8.4±1.7 mm, p<0.001). Mean follow-up was 525 days. Loss of IIA patency occurred in 2 SESG devices (8.33%) at 73 and 180 days postprocedure, and in zero BESG devices, however, this difference was not statistically significant (p=0.16). There was 1 IBE-related endoleak requiring reintervention during the study period. A BESG device required reintervention due to Type 3 endoleak at 284 days. CONCLUSIONS: There were no significant differences in outcomes between SESG and BESG when used for the IIA bridging stent in EVAR with IBE. The BESGs were associated with using 2 IIA bridging stents and were more often deployed in smaller IIA target arteries. Retrospective study design and small sample size may limit the generalizability of our findings. CLINICAL IMPACT: This series compares postoperative and midterm outcomes of self expanding stent grafts and balloon expandable stent grafts (BESG) when used as the internal iliac stent graft as part of a Gore® Excluder® Iliac Branch Endoprosthesis (IBE). With similar outcomes between the two stent-grafts, our series suggests that some of the advantages of BESG, device sizing, tracking, deployment, and profile, may be able to be leveraged without impacting the mid-term performance of the IBE.

In Vitro Geometry Analysis of Fenestrations in Endovascular Aneurysm Repair.

PURPOSE: Changes in the flared end of balloon-expandable covered stent (BECS) may precede BECS-associated complications but are not regularly assessed with computed tomographic angiography (CTA) after fenestrated endovascular aneurysm repair (FEVAR). Validation of the flare geometric analysis (FGA) and assessment of intraobserver and interobserver variability are investigated in this study. METHODS: Two series of 3 BeGraft BECSs (Bentley InnoMed GmbH, Hechingen, Germany) and 1 series of 3 Advanta V12 BECSs (Getinge AB, Göteborg, Sweden) were deployed in 3 side branches (45°, 60°, and 90° aortic branch angles) of an aorta phantom model. A standard post-FEVAR CTA scan was acquired. Computed tomographic angiography-derived measurements consisted of centerline reconstructions and placement of 3-dimensional coordinate markers by 2 observers in a vascular workstation. Flare geometric analysis calculates 3 BECS parameters: the circumferential flare-to-fenestration distance (FFD), which is the distance from the proximal end of the flare to fenestration, and diameters at the proximal end of the flare (Dflare) and at the fenestration (Dfenestration). Computed tomographic angiography-derived measurements were validated against microscopy measurements. Bland-Altman plots were used to determine the intraobserver and interobserver variability of the BECS parameters and intraclass correlation coefficient (ICC). RESULTS: For each BECS, the FFD at 4 equidistant quadrants of the circumference, Dflare, and Dfenestration were calculated. The mean difference and repeatability coefficient (RC) of the validation were 0.8 (2.1) mm for FFD, 0.4 (1.0) mm for Dflare, and -0.2 (1.2) mm for Dfenestration. The mean intraobserver and interobserver difference (RC) was 0.5 (1.6) mm and 0.7 (2.6) mm for FFD, 0.1 (0.6) mm and 0.1 (0.7) mm for Dflare, and -0.1 (0.8) mm and -0.8 (1.0) mm for Dfenestration. The mean ICC of intraobserver variability was 0.86 for FFD, 0.94 for Dflare, and 0.78 for Dfenestration. The mean ICC of interobserver variability was 0.77 for FFD, 0.92 for Dflare, and 0.48 for Dfenestration. CONCLUSION: This study showed that FGA of the flared ends of BECS can be performed with high accuracy in a phantom model, with good intraobserver and interobserver variability. Flare geometric analysis can be used to determine flare geometry of the BECS on standard post-FEVAR CTA scans.

Predicting Features of Visceral Stent Failure in Fenestrated Endovascular Aortic Aneurysm Repair.

PURPOSE: Visceral stents in fenestrated endovascular aortic repair (FEVAR) have a significant risk of complications and carry a considerable burden of reinterventions. The aim of this study is to identify preoperative and intraoperative predictors of visceral stent failure. MATERIALS: A retrospective review of 75 consecutive FEVARs in a single center from 2013 to 2021 was undertaken. Data on mortality, stent failure, and reintervention pertaining to 226 visceral stents were collected. METHODS: Anatomical features including aortic neck angulation, aneurysm diameter, and angulation of target viscerals were obtained from preoperative computed tomography (CT) scans. Stent oversizing and intraprocedural complications were recorded. Postoperative CT scans were analyzed to determine the length of cover of target vessels. RESULTS: Only bridging stents through fenestrations to visceral vessels were considered; 28 (37%) cases had 4 visceral stents, 24 (32%) had 3, 19 (25%) had 2, 4 (5%) had 1. Thirty day mortality was 8%, a third of which was related to visceral stent complications. Intraprocedural complexity was documented during the cannulation of 8 (3.5%) target vessels, with a technical success rate of 98.7%. A significant endoleak or visceral stent failure was identified in 22 stents (9.8%) postoperatively, of which 7 (3%) had in-patient reintervention within 30 days. Further reinterventions at 1, 2, and 3 years were 12 (5.4%), 2 (1%), and 1 (0.4%), respectively. Most reinterventions were for renal stents (n=19, 86%). A smaller stent diameter and a shorter length of visceral stent were significant predictors of failure. No other anatomical feature or stent choice was found to be a significant predictor of failure. CONCLUSIONS: The modality of visceral stent failures varies, but renal stents with a smaller diameter and/or shorter length are more likely to fail over time. Their complications and reinterventions are common and carry a significant burden; therefore, close surveillance must be continued long term. CLINICAL IMPACT: With this work we share the methodology adopted at our centre to treat juxtarenal aneurysm with FEVAR. Thanks to this detailed review of anatomical and technical features we provide guidance for endovascular surgeons to face hostile aneurysm with peculiar visceral vessels anatomy. With our findings will also motivate industries in their attempt to produce improved technologies able to overcome issues identified in this paper.

ABS-SMART (Aortic Balloon Supporting for Superior Mesenteric Artery Recanalization Technique): A New Technical Option for Recanalization of Complete Superior Mesenteric Artery Occlusion in Chronic Mesenteric Ischemia.

OBJECTIVE: To report our experience with a new technique for recanalization of the superior mesenteric artery (SMA)/celiac trunk (CT) with complete occlusion at the origin. TECHNIQUE: We describe our ABS-SMART (Aortic Balloon Supporting for Superior Mesenteric Artery Recanalization Technique) for recanalization of the CT and SMA in cases of complete occlusion of these arteries with a short or inexistent stump, which usually corresponds to chronic lesions with important calcification of the ostium. CONCLUSION: The ABS-SMART is an alternative for the recanalization of visceral arteries in cases where other conventional techniques have failed. It is particularly useful in scenarios characterized by a short occlusion at the origin of the target vessel, with no entry stump or severe calcification at the origin. CLINICAL IMPACT: Catheterization and recanalization of visceral stenoses may pose a challenge in some cases, as for example in the presence of a very narrow angle between the root or origin of the vessel and the aorta, as well as in the case of long and calcified stenoses, or when arteriography is unable to visualize the origin of the vessel. The present study describes our experience with the endovascular revascularization of visceral vessels using an aortic balloon-supported recanalization technique not previously described in the literature, that may be an effective alternative for the treatment of lesions of difficult access, such as total occlusion at the origin of the target vessel, with no entry stump or severe calcification at the origin of the SMA and CT, by improving the chances for technical success.

Treatment of 12-year-old girl with midaortic syndrome by using Cook Formula stent.

Middle aortic syndrome is a severe form of aortic coarctation and mostly involves the thoracic and abdominal part of the aorta. Traditional surgical approach has some potential risks and repetitive operations. Percutaneous stent implantation is a feasible and safe method for the palliation of middle aortic syndrome in childhood. Herein, a child with middle aortic syndrome was presented who has been treated by transcatheter stent implantation.

Chimney Endovascular Aneurysm Repair Using Endurant Stent-Grafts With Bare Balloon-Expandable Stents for Patients With Juxtarenal Aortic Aneurysms.

PURPOSE: To evaluate the advantages of chimney endovascular aneurysm repair (chEVAR) using an Endurant stent-graft with uncovered balloon-expandable stents (BES) for patients with juxtarenal aortic aneurysms. MATERIALS AND METHODS: Twenty-two patients (mean age 78.5±9.0 years; 13 men) who underwent chEVAR using Endurant and uncovered BES between January 2014 and December 2017 were analyzed retrospectively. The maximum aneurysm diameter was 59.1±11.9 mm, and the proximal neck length was 5.2±2.9 mm. Of the 22 cases, 9 (40%) involved proximal neck angulation and 9 (40%) had a conical neck. Single and double chimneys were performed using BES in 19 and 3 cases, respectively. In 2 cases, an additional self-expanding covered stent was used inside the uncovered BES. RESULTS: The technical success was 91% (20/22) as 2 (9%) cases showed minor type Ia endoleak. No postoperative systemic complications or acute renal dysfunction (Acute Kidney Injury Network classification stage 2 or higher) were observed. The mean radiologic observation period was 16.1±9.6 months, and no aneurysm expansion (>5 mm) was observed during this time. The mean maximum aneurysm diameter decreased to 52.9±10.2 mm (p<0.001 vs preoperative), with an individual mean sac regression of 6.2±5.9 mm. Overall primary chimney stent patency was 100%. One of the 2 cases of intraoperative type Ia endoleak resolved at the 6-month imaging, and no new type Ia endoleaks developed in any cases at follow-up. No additional treatment- or aneurysm-related events were observed. CONCLUSION: Short-term outcomes of chEVAR using Endurant with uncovered BES have been favorable when covered stents were unavailable, and it can be useful for high-risk patients with juxtarenal aortic aneurysms.

Comparison of self-expanding stents with distal embolic protection to balloon-expandable stents without a protection device in the treatment of symptomatic vertebral artery origin stenosis: a prospective randomized trial.

PURPOSE: To compare the angiographic and clinical outcomes of self-expanding stents (SES) with distal embolic protection devices (EPD) vs balloon-expandable stents (BES) without EPD in the treatment of symptomatic atherosclerotic vertebral artery ostial stenosis (VAOS). METHODS: Between July 2011 and March 2013, a prospective randomized trial was conducted involving 127 patients (mean age 67.3±10.2 years; 94 men) with symptomatic VAOS randomly assigned to treatment with SES + EPD (Precise RX or RX Acculink stent + Spider FX EPD; n=61) or BES (Palmaz Blue or Resolute RX; n=66) without EPD. In-stent restenosis (ISR) >50% detected by duplex ultrasound was the primary endpoint. Technical success, clinical success, complications within 30 days, and signal intensity abnormalities on diffusion weighted imaging (DWI) after stenting were compared. RESULTS: The 30-day technical success rate was 95.5% (63/66) for SES+EPD vs 100% (70/70) for BES without EPD (p=0.072). DWI at 24 hours poststenting showed 2 hyperintense lesions in 2 (3.3%) SES + EPD cases and 15 hyperintense lesions in 13 (18.6%) BES patients (p<0.01). At a mean 18-month follow-up, the clinical success rate was 93.9% (62/66) for the SES + EPD group vs 85.7% (60/70) for the BES group (p=0.115). The ISR was seen in 16/70 (22.9%) arteries in the BES group and 2/66 (3.1%) arteries in SES + EPD group (p<0.01). Target vessel revascularization was performed in 7 (10.0%) BES arteries vs none in the SES + EPD group (p<0.01). CONCLUSION: SES with EPD in the treatment of symptomatic VAOS is technically feasible and safe, with low rates of ISR and significantly reduced thromboembolic events on imaging when compared to BES without EPD.

Current evidence regarding chimney graft occlusions in the endovascular treatment of pararenal aortic pathologies: a systematic review with pooled data analysis.

PURPOSE: To review the literature on pararenal endovascular aneurysm repair (EVAR) to determine the frequency and clinical relevance of chimney graft occlusions. METHODS: A comprehensive search of the English-language literature abstracted in the Medline and the Cochrane Library databases was performed to identify case series involving pararenal aortic pathologies (degenerative aneurysms, penetrating atherosclerotic ulcers, type Ia endoleaks, and para-anastomotic aneurysms) treated with EVAR and chimney grafts; thoracoabdominal, iliac, or aortic arch chimney graft placements were excluded, as were case reports in which the total number of chimney grafts implanted at the reporting center could not be determined. The literature search identified 83 studies regarding chimneys/snorkels for pararenal pathologies published between January 2007 and March 2014. Of these, 7 studies met the inclusion criteria and were included in the analysis. RESULTS: There were 15 (4.5%) occlusions in the overall 334 renovisceral vessels in which chimney grafts were deployed. The mean time to chimney graft occlusion was 3.5 months (range 1-270 days) over a mean follow-up of 1.4 months (range 9-24). The target arteries were the renal artery (n=12) and the superior mesenteric artery (SMA; n=3). Seven patients were asymptomatic, and no description was given in 5 cases. In the other 3 patients, the symptoms were acute renal failure, intestinal ischemia, and malignant hypertension. The treatment strategy included open conversion and iliorenal bypass (n=1), exploratory laparotomy to revascularize the SMA (n=1), hemodialysis (n=1), placement of bare metal stents (n=4), conservative treatment (n=2), and unknown (n=6). One (6.7%) patient died (an occluded SMA). Two patients with renal chimney occlusion suffered from temporary renal function deterioration. CONCLUSION: The present analysis identified a low rate of chimney graft occlusions, which appear to occur generally a few months after placement. Involvement of the renal artery had no severe clinical consequences, while occlusion of the SMA can be associated with life-threatening complications. More detailed information regarding occluded chimney grafts will be needed in future publications to help identify the causes.

Rescue extracranial vertebral stenting in tandem occlusions: A preliminary Vietnamese study.

BACKGROUND AND PURPOSE: The acute vertebrobasilar occlusion associated with the poor prognosis, particularly tandem occlusion. However, few data on the efficacy of the endovascular therapy was indicated in this occlusion. We investigated whether the additional rescue extracranial vertebral stenting improved clinical outcome by modified Rankin scale (mRS) score within 3 months after the procedure. METHODS: This was a retrospective analysis of patients with acute posterior tandem occlusion who were treated with rescue extracranial vertebral stenting between December 2020 and January 2024 at our hospital. Clinical, neuroimaging, procedural, and complication data were collected. Primary outcomes included the rate of good outcomes (mRS ≤ 2) at 3-month follow-up. RESULTS: Nine patients who underwent rescue extracranial vertebral stenting in posterior circulation tandem occlusions were enrolled in the study. All patients were achieved the successful recanalization (mTICI ≥ 2b). Of Dotter technique in the "distal-to-proximal" approach, Diagnostic-Dotter made up 66.7%. Five patients (55.6%) with good outcome (mRS ≤ 2) at 3 months, and 1 patient (11.1%) underwent suboccipital decompressive craniectomy due to the malignant cerebellar infarction. CONCLUSION: Our study suggests that despite the small series with posterior tandem occlusions, the rescue extracranial vertebral stenting could be an important alternative treatment followed by mechanical thrombectomy.

Self-expanding versus balloon expandable stent for intracranial arterial stenosis: A systematic review and meta-analysis.

BACKGROUND AND PURPOSE: There are limited data regarding the comparison of balloon expandable stents (BES) and self-expanding stents (SES) for the treatment of intracranial arterial stenosis. METHODS: We conducted a systematic review to identify studies that compared SES and BES in patients with symptomatic intracranial arterial stenosis. Data were extracted from relevant studies found through a search of PubMed, Scopus, and Web of Science until from January 1, 2010 to September 28, 2023. Statistical pooling with random-effects meta-analysis was undertaken to compare the rates/severity of postprocedure stenosis, technical success, 30-day stroke and/or death, cumulative clinical endpoints, and restenosis rates. RESULTS: A total of 20 studies were included. The standardized mean difference (SMD) for postprocedure stenosis (%) was significantly lower (SMD: -0.52, 95% confidence interval [CI]: -0.79 to -0.24, p < .001, 10 studies involving 1515 patients) with BES. The odds for 30-day stroke and/or death were significantly lower (odds ratio [OR] 0.68, 95% CI: 0.50-0.94, p = .019, 15 studies involving 2431 patients), and cumulative clinical endpoints on follow-up were nonsignificantly lower (OR 0.64, 95% CI: 0.30-1.37, p = .250, 10 studies involving 947 patients) with BES. The odds for restenosis during follow-up were significantly lower (OR 0.50, 95% CI: 0.31-0.80, p = .004, 13 studies involving 1115 patients) with BES. CONCLUSIONS: Compared with SES, BES were associated with lower rates of postprocedure 30-day stroke and/or death with lower rates of restenosis during follow up and the treatment of symptomatic intracranial arterial stenosis.

Balloon-Expandable Cheatham-Platinum Stents Versus Self-Expandable Nitinol Stents in Coarctation of Aorta: A Randomized Controlled Trial.

OBJECTIVES: This study sought to compare the safety and efficacy of the balloon-expandable stent (BES) and the self-expandable stent (SES) in the endovascular treatment of coarctation of aorta. BACKGROUND: Coarctoplasty with stents has conferred promising results. Although several nonrandomized studies have approved the safety and efficacy of the BES and the SES, no high-quality evidence exists for this comparison. METHODS: In the present open-label, parallel-group, blinded endpoint randomized pilot clinical trial, adult patients with de novo native aortic coarctation were randomized into Cheatham-platinum BES and uncovered nitinol SES groups. The primary outcome of the study was a composite of procedural and vascular complications. The secondary outcomes of the study consisted of the incidence of aortic recoarctation, thoracic aortic aneurysm/pseudoaneurysm formation, and residual hypertension at a 12-month follow-up. RESULTS: Among 105 patients who were screened between January 2017 and December 2019, 92 eligible patients (32 women [34.8%]) with a median age of 30 years (IQR: 20-36 years) were randomized equally into the BES and SES groups. The composite of procedural and vascular complications occurred in 10.9% of the BES group and 2.2% of the SES group (odds ratio: 0.18; 95% CI: 0.02-1.62; P = 0.20). Aortic recoarctation occurred in 5 patients (5.4%), 3 patients (6.5%) in the BES group and 2 patients (4.3%) in the SES group (odds ratio: 0.65; 95% CI: 0.10-4.09; P = 0.64). Only 1 patient (1.1%) was complicated by aortic pseudoaneurysm. Hypertension control was achieved in 50% of the study population, with an equal distribution in the 2 study groups at the 12-month follow-up. CONCLUSIONS: Both the BES and the SES were safe and effective in the treatment of native coarctation.

Button battery removed from the stomach resulting in a missed aortoesophageal fistula - a multidisciplinary approach to rescuing a very young patient: a case report.

BACKGROUND: While coins are still the most common foreign bodies swallowed by children, ingestion of batteries has become more frequent among children due to the increasing access to electronic toys and devices. Coin battery ingestion is potentially life threatening for children. Aortoesophageal fistula is the most common cause of death in children who have swallowed coin batteries, and there have not been any reported survivors. CASE PRESENTATION: A 3-year-old Caucasian girl presented to the emergency room of a community hospital complaining of abdominal pain. An abdominal X-ray showed a coin lithium battery located in the fundus of her stomach, and she was transferred to a referral pediatric hospital. In the following hours she developed massive hematemesis and severe hypovolemic shock. An emergency laparotomy was attempted, and the coin battery was removed. The initial surgery and multiple blood transfusions did not, however, improve the clinical situation. She was then referred to our tertiary referral center, where a multidisciplinary team decided to attempt a combined angiographic and endoscopic approach to resolve a life-threatening aortoesophageal fistula. A 3-year follow-up was uneventful. CONCLUSIONS: Coin batteries are designed for a wide variety of small appliances, such as hearing aids, watches, remote controls, and toys. Although a change in the clinical approach to battery ingestion is needed to avoid misdiagnosis or delayed treatment, primary prevention of battery ingestion would be even more effective than an improved treatment.

Thrombogenic superior vena cava syndrome from long-standing central venous access in a 5-year-old patient treated with balloon-expandable stents.

Thrombogenic superior vena cava syndrome is an uncommon, dangerous complication of long-standing central venous catheter use. The increased use of central venous catheters has resulted in more non-malignant cases of superior vena cava syndrome across all age groups. We present a 5-year-old male with superior vena cava syndrome associated with acute onset of severe upper extremity and facial swelling, dyspnea, and a right subclavian central venous catheter malfunction. The patient was ultimately treated with percutaneous stenting of the superior vena cava with balloon-expandable Palmaz stents following unsuccessful angioplasty, catheter-directed thrombolysis, and percutaneous thrombectomy. This case highlights a relatively uncommon complication in children from long-term central venous catheter access and describes an emerging, minimally-invasive therapeutic alternative that allows for preservation of age-appropriate superior vena cava luminal diameter as patients grow.

Self-Expanding Versus Balloon-Expandable Stents for Iliac Artery Occlusive Disease: The Randomized ICE Trial.

OBJECTIVES: Atherosclerosis of iliac arteries is widespread. As inflow vessels, they are of great clinical significance and increasingly being treated by endovascular means. Most commonly, stents are implanted. BACKGROUND: So far, due to a lack of comparative data, no guideline recommendations on the preferable stent type, balloon-expandable stent (BE) or self-expanding stent (SE), have been issued. METHODS: In this randomized, multicenter study, patients with moderate to severe claudication from common or external iliac artery occlusive disease were assigned 1:1 to either BE or SE. The primary endpoint was binary restenosis at 12 months as determined by duplex ultrasound. Key secondary endpoints were walking impairment, freedom from target lesion revascularization (TLR), hemodynamic success, target limb amputation, and all-cause death. RESULTS: Six hundred sixty patients with 660 lesions were enrolled at 18 German and Swiss sites over a period of 34 months; 24.8% of the patients had diabetes and 57.4% were current smokers. The common iliac artery was affected in 58.9%. One hundred nine (16.5%) lesions were totally occluded and 25.6% heavily calcified. Twelve-month incidence of restenosis was 6.1% after SE implantation and 14.9% after BE implantation (p = 0.006). Kaplan-Meier estimate of freedom from TLR was 97.2% and 93.6%, respectively (p = 0.042). There was no between-group difference in walking impairment, hemodynamic success, amputation rate, all-cause death, or periprocedural complications. CONCLUSIONS: The treatment of iliac artery occlusive disease with SE as compared with BE resulted in a lower 12-month restenosis rate and a significantly reduced TLR rate. No safety concerns arose in both groups. (Iliac, Common and External [ICE] Artery Stent Trial; NCT01305174).