Endovascular Aneurysm Repair Devices as a Use Case for Postmarketing Surveillance of Medical Devices.

Importance: The US Food and Drug Administration (FDA) is building a national postmarketing surveillance system for medical devices, moving to a "total product life cycle" approach whereby more limited premarketing data are balanced with postmarketing surveillance to capture rare adverse events and long-term safety issues. Objective: To assess the methodological requirements and feasibility of postmarketing device surveillance using endovascular aneurysm repair devices (EVARs), which have been the subject of safety concerns, using clinical data from a large health care system. Design, Setting, and Participants: This retrospective cohort study included patients with electronic health record (EHR) data in the Veterans Affairs Corporate Data Warehouse. Exposure: Implantation of an AFX Endovascular AAA System (AFX) device (any of 3 iterations) or a non-AFX comparator EVAR device from January 1, 2011, to December 21, 2021. Main Outcomes and Measures: The primary outcomes were rates of type III endoleaks and all-cause mortality; and rates of these outcomes associated with AFX devices compared with non-AFX devices, assessed using Cox proportional hazards regression models and doubly robust causal modeling. Information on type III endoleaks was available only as free-text mentions in clinical notes, while all-cause mortality data could be extracted using structured data. Device-specific information required by the FDA is ascertained using unique device identifiers (UDIs), which include factors such as model numbers, catalog numbers, and manufacturer-specific product codes. The availability of UDIs in EHRs was assessed. Results: In total, 13 941 patients (mean [SD] age, 71.8 [7.4] years) received 1 of the devices of interest (AFX with Strata [AFX-S]: 718 patients [5.2%]; AFX with Duraply [AFX-D]: 404 patients [2.9%]; or AFX2: 682 patients [4.9%]), and 12 137 (87.1%) received non-AFX devices. The UDIs were not recorded in the EHR for any patient with an AFX device, and partial UDIs were available for 19 patients (0.1%) with a non-AFX device. This necessitated the development of advanced natural language processing tools to define the cohort of patients for analysis. The study identified a significantly higher risk of type III endoleaks at 5 years among patients receiving any of the AFX device iterations, including the most recent version, AFX2 (11.6%; 95% CI, 8.1%-15.1%) compared with that among patients with non-AFX devices (5.7%; 95% CI, 2.2%-9.2%; absolute risk difference, 5.9%; 95% CI, 2.3%-9.4%). However, there was no significantly higher all-cause mortality for any of the AFX device iterations, including for AFX2 (19.0%; 95% CI, 16.0%-22.0%) compared with non-AFX devices (18.0%; 95% CI, 15.0%-21.0%; absolute risk difference, 1.0%; 95% CI, -2.1% to 4.1%). Conclusions and Relevance: The findings of this cohort study suggest that clinical data can be used for the postmarketing device surveillance required by the FDA. The study also highlights ongoing challenges to performing larger-scale surveillance, including lack of consistent use of UDIs and insufficient relevant structured data to efficiently capture certain outcomes of interest.

Reduction of rupture risk in ICA aneurysms by endovascular techniques of coiling and stent: numerical study.

The initiation, growth, and rupture of cerebral aneurysms are directly associated with Hemodynamic factors. This report tries to disclose effects of endovascular technique (coiling and stenting) on the quantitative intra-aneurysmal hemodynamic and the rupture of cerebral aneurysms. In this paper, Computational Fluid Dynamic are done to investigate and compare blood hemodynamic inside aneurysm under effects of deformation (due to stent) and coiling of aneurysm. The blood stream inside the sac of aneurysm as well as pressure and OSI distribution on the aneurysm wall are compared in nine cases and results of two distinctive cases are compared and reported. Obtained results specifies that the mean WSS is reduced up to 20% via coiling of the aneurysm while the deformation of the aneurysm (applying stent) could reduce the mean WSS up to 71%. In addition, comparison of the blood hemodynamic shows that the blood bifurcation occurs in the dome of aneurysm when endovascular technique for the treatment is not applied. It is found that the bifurcation occurs at ostium section when ICA aneurysm is deformed by the application of stent. The impacts of coiling are mainly limited since the blood flow entrance is not limited in this technique and WSS is not reduced substantial. However, usage of stent deforms the aneurysm angle with the orientation of parent vessel and this reduces blood velocity at entrance of the ostium and consequently, WSS is decreased when deformation of the aneurysm fully occurs. These qualitative procedures provide a preliminary idea for more profound quantitative examination intended for assigning aneurysm risk of upcoming rupture.

Clinical Features and Treatment Outcomes of Pseudoaneurysm Following Pancreatic Resection.

BACKGROUND/AIM: Management strategies for pseudoaneurysm rupture after pancreatic resection have not yet been firmly established due to its low incidence and effects of environmental variability among centers. This study aimed to provide a basis for treatment strategy improvement. PATIENTS AND METHODS: Clinical features and outcomes of 29 patients who experienced pseudoaneurysm formation or rupture following pancreatic resection were retrospectively reviewed. RESULTS: The incidence of pseudoaneurysm formation was 2.8%. In 28 of 29 patients, pseudoaneurysm was identified via emergent dynamic computed tomography (CT). The rates of complete cessation of bleeding by interventional radiology (IVR) and surgical intervention were 88% and 100%, respectively. Mortality rate was 13.8%. Four patients treated by IVR died, including three of massive bleeding and one of liver failure. CONCLUSION: Patients with suspected pseudoaneurysm rupture after pancreatic resection should undergo immediate CT. Open surgery is preferable for patients with incomplete hemostasis by IVR or those who cannot immediately undergo IVR, however, IVR is an effective alternative.

A review of the incidence, outcome, and management of venous stent migration.

BACKGROUND: Percutaneous endovenous stenting has emerged during the past decade as the primary method of treating symptomatic venous outflow obstruction. A recognized complication of venous stenting is stent migration. The aim of the present systematic review was to identify the number of cases of stent migration in reported studies to recognize the risk factors that might be associated with this complication and the outcomes following migration. METHODS: A review was conducted in accordance with the MOOSE (meta-analyses of observational studies in epidemiology) and PRIMSA (preferred reporting items for systematic review and meta-analysis) guidelines and registered in the PROSPERO. MEDLINE, EMBASE, and PubMed databases. Key references were searched using specified keywords. All relevant data for the primary procedure and subsequent presentation with stent migration were retrieved. The data were assessed as too low in quality to allow for statistical analysis. RESULTS: Between 1994 and 2020, 31 studies were identified, including 29 case reports and 2 case series, providing data for 54 events of venous stent migration with some data provided regarding the stent used for 47 of the events. The mean age of the 52 patients with stent migration was 50 years (range, 19-88 years) and 30 were men (57.6%). The stents for most of the reported cases were ≤60 mm in length (38 of 46; 82.6%). Only three of the reports were of stents >14 mm in diameter (3 of 47; 3.6%). None of the studies had reported migration of stents >100 mm long. In 85% of the migrated stent events, retrieval was attempted, with 65.2% via an endovascular approach. The immediate outcome was satisfactory for 100% of the reported attempts, whether by an endovascular or open surgical approach. CONCLUSIONS: The findings from our literature review suggest that the risk of migration is rare but might be underreported. Most of reported cases had occurred with shorter and smaller diameter stents. The paucity of reported data and the short-term follow-up provided suggest that more formal data collection would provide a truer reflection of the incidence. However, clear strategies to avoid migration should be followed to prevent this complication from occurring.

Intraoperative cone beam computed tomography to improve outcomes after infrarenal endovascular aortic repair.

OBJECTIVE: We evaluated whether a combination of intraoperative contrast-enhanced cone beam computed tomography (ceCBCT) and postoperative contrast-enhanced ultrasound (CEUS) after infrarenal endovascular abdominal aortic aneurysm repair (EVAR) could reduce late stent graft-related complications and, consequently, reintervention. METHODS: All consecutive patients who had received infrarenal bifurcated stent grafts in our hybrid room (IGS 730; GE Healthcare, Île-de-France, France) during two discrete periods were included in the present study. From November 2012 to September 2013, two-dimensional completion angiography was performed after each EVAR, followed by computed tomography angiography (CTA) before discharge (group 1). From October 2013 to January 2015, intraoperative ceCBCT was performed, followed by CEUS within the first postoperative days (group 2). Comparative analyses of the outcomes were performed. The primary endpoint was late stent graft-related complications, a composite factor incorporating aneurysm-related death, type I or III endoleaks, kink or occlusion of the iliac limb, and aortic sac enlargement after the first 30 postoperative days. The secondary endpoint was all stent graft-related reinterventions. All-cause and aneurysm-related deaths were also recorded. RESULTS: Overall, 100 consecutive patients (50 each in groups 1 and 2) were enrolled, with a median follow-up of 60 months (interquartile range, 41-69 months). At 60 months after the index procedure, the freedom from late stent graft-related complications in each group was 61.6% (95% confidence interval [CI], 47.0%-80.6%) for group 1 and 81.7% (95% CI, 70.1%-95.2%) for group 2 (P = .033). The use of intraoperative ceCBCT was independently associated with a reduced rate of late stent graft-related complications on multivariate analysis (hazard ratio, 0.39; 95% CI, 0.16-0.95; P = .038) but did not appear to significantly protect against stent graft-related reinterventions (hazard ratio, 0.53; 95% CI, 0.20-1.39; P = .198) or all-cause death (P = .47). CONCLUSIONS: To the best of our knowledge, the present study is the first to report the influence of routine ceCBCT on late outcomes after EVAR. The use of ceCBCT shows the potential for reducing late stent graft-related complications associated.

An overview of in-stent restenosis in iliofemoral venous stents.

BACKGROUND: Although endovenous stents have been associated with overall low morbidity, they can require reinterventions to correct stent malfunction due to in-stent restenosis (ISR). ISR has often occurred iliofemoral venous stents but has not been well described. It has been reported to develop in >70% of patients who have undergone iliofemoral venous stenting. We sought to provide an overview of ISR in iliofemoral venous stents, including the pathologic, diagnostic, and management considerations and the identification of several areas of potential research in the future. METHODS: A search of reported English-language studies was performed in PubMed and the Cochrane Library. "In-stent restenosis," "vein," "venous," "iliac," and "iliofemoral" were used as keywords. The pertinent reports included in the present review had addressed the pathology, diagnosis, and current management options for ISR. RESULTS: ISR refers to the narrowing of the luminal caliber of the stent owing to the development of stenosis inside the stent itself. ISR should be differentiated from stent compression. Two main types of ISR have been described: soft and hard lesions. These lesions respond differently to angioplasty. Stent inflow and shear stress are important factors in the development of ISR. The treatment options available at present include balloon angioplasty (hyperdilation or isodilation), laser ablation, atherectomy, and Z-stent placement. CONCLUSIONS: Reintervention for ISR should be determined by the presence of residual or recurrent symptoms and not simply by a numeric value obtained from an imaging study. Overall stent occlusion due to ISR is rare, and no role exists for prophylactic angioplasty to treat asymptomatic ISR. The current treatment options for ISR are mostly durable and effective. However, more research is needed on methods to prevent the development of ISR. The role of antiplatelet and anticoagulant agents in the prevention of ISR requires further investigation, with particular attention to unique subset of patients (after thrombosis vs nonthrombotic iliac vein lesions). For high-risk, post-thrombotic patients, anticoagulation can be considered to prevent ISR. The role of triple therapy (anticoagulation and dual antiplatelet therapy) in the prevention of ISR remains unclear.

Sheath-Anchoring for Rail Guidewire Technique to Advance and Deploy Thoracic Endograft in Hostile Anatomy.

BACKGROUND: To describe a bailout technique to advance and precisely deploy thoracic endograft in the ascending aorta in case of difficulty crossing the aortic arch. CASE REPORTS: A 73-year-old man presented with a large ruptured aneurysms in the descending aorta. During the TEVAR, stent-graft passage through the aortic arch was impossible due to the severe tortuosity of the aorta. The problem has been resolved using the sheath-anchoring rail guidewire (SARG) technique. RESULTS: Through an axillary access, a snare was used to capture the stiff wire from the femoral access. A sheath was advanced over the stiff wire to the ascending aorta and placed there. By exploiting the grip of the sheath on the stiff in the ascending aorta, it was possible to handle the tension, move the delivery system through the arch and carefully deploy the graft. CONCLUSION: The SARG is a simple and quick learning technique which can be useful for Physicians dealing with complex aortic arch anatomy.

Midterm Outcomes of an Adjustable Puncture Device for In Situ Fenestration During Thoracic Endovascular Aortic Repair.

OBJECTIVE: To evaluate the midterm outcomes of in situ fenestration (ISF) with an adjustable puncture device for aortic arch branch preservation during thoracic endovascular aortic repair (TEVAR). METHODS: From October 2016 to April 2019, patients with complicated type B aortic dissection, thoracic aortic aneurysm > 5.5 cm in diameter, or aortic penetrating ulcer with a base > 20 mm or depth > 15 mm, who received TEVAR requiring a proximal sealing beyond zone 3 and underwent ISF using an adjustable puncture device, were included. After the procedure, patients were monitored at one, three, six, and 12 months, and annually thereafter. Peri-operative and follow up data were collected and analysed. RESULTS: Fifty of 51 patients (98%) received successful ISFs. One, two, or three aortic arch branches were preserved in 44, six, and one patient, respectively. Intra-operatively, eight type Ia endoleaks and one type II endoleak were found on angiography. One patient died of cerebral hernia three days post-procedure from a severe stroke; one patient suffered from transient paraplegia but recovered in two weeks; one patient had a non-disabling stroke. The median follow up was 31 months (22.5 - 36.5 months). At six month follow up, all nine unmanaged endoleaks had disappeared. One new type Ia endoleak was identified in a patient at the one month follow up which resolved spontaneously one year later. All revascularised arteries were patent at the last follow up. No fractures, migrations, or bridging stent kinks were found. CONCLUSION: In this largest mechanical based ISF study to date, an adjustable puncture device was shown to facilitate the procedure of ISF during endovascular repair of aortic diseases involving the aortic arch, with high success. The midterm outcome demonstrates the efficacy and safety of the device in assisting with preservation of aortic arch branches.

Outcomes of Same-Day Discharge with Manual Compression and 5F Sheath Compatible Devices for Lower Extremity Arterial Endovascular Treatment.

BACKGROUND: For same-day discharge lower extremity arterial disease (LEAD) endovascular procedures, femoral manual compression could be an alternative to arterial closure devices. The aim of this study was to assess the security and efficacy of same-day discharge after manual compression in patients treated for LEAD endovascular revascularization with 5F sheath. METHODS: FREEDOM OP was a national multicenter, prospective, single arm study. Patients with symptomatic LEAD (Rutherford 2-5) and eligible for same-day discharge were included. The primary endpoint was the total in-hospital admission rate, which includes overnight surveillance and rehospitalization rate at 1 month. RESULTS: Between September 2017 and August 2019, 114 patients were included. The mean age of the patients was 66 ± 10 years and most of them were claudicant (103; 94%). Mainly femoropopliteal lesions were treated (178; 70%) and the technical success was 97%. One hundred forty-two 5F stents and fifty one 5F drug coated balloon were delivered. The mean manual compression duration was 13 ± 4 min. Major access-related complications rate was 4.5%. Total in-hospital admission rate was 11%. Seven patients had overnight surveillance and 5 were rehospitalized (2 for the target lesion). No rehospitalisation was carried out within 24 hr after discharge. No major cardiovascular event, including death, was observed. The patients were significantly improved in term of clinical status (P < 0.0001) and hemodynamic (P < 0.0001) in comparison to baseline. CONCLUSION: FREEDOM OP showed that manual compression is feasible and safe for same-day discharge after LEAD revascularization with 5F sheath femoral approach.

Hemodynamic Effect of Resuscitative Endovascular Balloon Occlusion of the Aorta in Hemodynamic Instability Secondary to Acute Cardiac Tamponade in a Porcine Model.

BACKGROUND: The pre-hospital use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) is increasing, although it remains controversial, in part because of suggested contraindications such as acute cardiac tamponade (ACT). As both the pre-hospital and in-hospital use of REBOA might potentially occur with concurrent ACT, knowledge of the hemodynamic effect of REBOA in this setting is crucial. This study, therefore, aimed at investigating the physiological effects of REBOA in hemodynamic instability secondary to ACT in a porcine model. We hypothesize that REBOA can temporarily increase systemic blood pressure and carotid blood flow, and prolong survival, in hemodynamic shock caused by ACT. METHODS: Fourteen pigs (24-38 kg) underwent ACT, through true cardiac injury and hemorrhage into the pericardial space, and were allowed to hemodynamically deteriorate. At a systolic blood pressure (SBP) of 50 mm Hg (SBP50) they were randomized to total occlusion REBOA in zone 1 or to a control group. Survival, hemodynamic parameters, carotid blood flow (CBF), femoral blood flow (FBF), cardiac output (CO), end-tidal CO2, and arterial blood gas parameters were analyzed. RESULTS: REBOA intervention was associated with a significant increase in SBP (50 mm Hg to 74 mm Hg, P = 0.016) and CBF (110 mL/min to 195 mL/min, P = 0.031), with no change in CO, compared to the control group. At 20 min after SBP50, the survival rate in the intervention group was 86% and in the control group 14%, with time to death being significantly longer in the intervention group. CONCLUSIONS: This randomized animal study demonstrates that REBOA can help provide hemodynamic stabilization and prolong survival in hemodynamic shock provoked by ACT. It is important to stress that our study does not change the fact that urgent pericardiocentesis or cardiac surgery is, and should remain, the standard optimal treatment for ACT.Level of evidence: Prospective, randomized, experimental animal study. Basic science study, therapeutic.

The "Skewer Technique" for Stentgraft Delivery in the Aortic Arch: Advancing the Dilatator in The Innominate Artery Over a Right Femoro-Brachial Through-And-Through Wire.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) is the preferred treatment for different aortic pathologies, because it has reduced mortality and morbidity rates. However, TEVAR is not feasible in all cases due to aortic angulations, the hemodynamics of the aortic arch and narrow or tortuous iliofemoral access. Therefore, different adjuvant techniques, such as iliac percutaneous transluminal angioplasty, iliathrough-and-through guidewires and external transapical guidewires have been previously reported. Herein we describe the Skewer Technique for successful TEVAR delivery, through a right-brachial-femoral through-and-through guidewire and advancement of the delivery system into the innominate artery. METHODS: A 38-year-old male presented with a symptomatic 11.5cm thoracic aneurysm with involvement of the left-subclavian artery ostium. The patient underwent left carotid-subclavian bypass and a TEVAR. Due to the huge size of the aneurysm a left-brachial-right femoral artery through-and-through guidewire was established. However, the achievement of a stable position for the deployment of the stentgraft was not possible. Eventually, the exclusion of the aneurysm was done with a right brachio-femoral through-and-through wire, inserting the proximal part of the delivery system into the innominate artery. CONCLUSIONS: The use of adjuvant techniques such as a through-and-through right brachial-femoral guidewire with advancement of the endograft delivery system in the innominate artery (Skewer Technique) represents a useful alternative option in cases where the angulations of the aortic arch impede the deployment of the stent graft using conventional techniques.

Incidence, predictive factors, and outcomes of intraprocedure adverse events during fenestrated-branched endovascular aortic repair of complex abdominal and thoracoabdominal aortic aneurysms.

OBJECTIVE: To evaluate the incidence of intraoperative adverse events (IAEs) and their impact on outcomes after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysm (TAAAs). METHODS: We reviewed the clinical and imaging data of 600 consecutive patients (445 males; mean age, 75 ± 8 years) who underwent FB-EVAR between 2007 and 2019 in a single institution. IAE was defined as any intraoperative complication or technical problem requiring additional and unplanned procedures, and was classified as access-related, target artery (TA)-related, or graft-related. End points included rates of IAEs, 30-day or in-hospital mortality, major adverse events, patient survival, freedom from secondary intervention, and TA instability. RESULTS: A total of 122 IAEs were identified in 105 patients (18%). IAEs were TA-related in 55 patients (9%), access-related in 46 patients (8%), and graft-related in seven patients (1%). Female sex was more frequent among patients with IAEs (44% vs 22%; P < .001). Patients with IAEs had smaller renal artery diameter (-0.4 mm, 5.4 ± 0.8 mm vs 5.8 ± 0.9 mm; P < .001), and were treated more often for TAAAs (72% vs 54%; P < .03). Technical success was achieved in 96.5% of patients and was lower for patients with IAEs (82% vs 99%; P < .001). Major adverse events were significantly more frequent among patients who had IAEs (odds ratio [OR], 1.98; 95% confidence interval [CI], 1.21-3.25), most due to acute kidney injury (27% vs 11%; P < .001) including new-onset dialysis (5% vs 1%; P = .01). On multivariate logistic regression model, female sex (OR, 2.5; 95% CI, 1.5-4.0), TA stenosis >50% (OR, 2.0; 95% CI, 1.3-3.3), and Crawford Extent II TAAA (OR, 1.9; 95% CI, 1.1-3.3) were predictive of IAEs, whereas preloaded design (OR, 0.6; 95% CI, 0.4-0.9) and TA diameter (+1 mm; OR, 0.6; 95% CI, 0.4-0.9) were protective of IAEs. IAEs negatively affected secondary intervention (hazard ratio [HR], 1.6; 95% CI, 1.1-2.3) and TA instability (HR, 2.5; 95% CI, 1.2-5.4); however, IAEs did not affect patient survival (HR, 1.0; 95% CI, 0.7-1.4). CONCLUSIONS: IAEs are common, occurring in nearly one of five patients treated with FB-EVAR for complex aortic aneurysms, and have a negative impact on clinical outcomes. IAEs were associated with female sex, TA diameter, and more extensive aortic disease.

Early clinical outcomes of retrograde in situ branched stent grafting for complex aortic arch aneurysms.

OBJECTIVE: To evaluate the early outcomes of retrograde in situ branched stent grafting (RIBS) using the gutter balloon technique for complex aortic arch aneurysms (CAAs). METHODS: The RIBS technique is an in situ needle fenestration procedure during thoracic endovascular aortic repair with the reconstruction of cervical branches. The double RIBS (D-RIBS) for the reconstruction of the left common carotid artery and the brachiocephalic artery using the gutter balloon technique was performed in 30 high-risk patients. We describe the early clinical results of the D-RIBS technique for CAAs. Primary end points were technical success and 30-day mortality. Secondary end points were postoperative complications, rates of endoleaks, overall survival, aneurysm-related death, and reinterventions. RESULTS: The mean age was 77.1 ± 6.6 years, and the mean maximum minor-axis aneurysmal diameter was 65.9 ± 8.9 mm. Twenty-six patients underwent D-RIBS for elective arch aortic aneurysm, and four patients were for reintervention after zone 2 thoracic endovascular aortic repair failure. Stent graft puncture was performed 60 times from the common carotid arteries, and technical success was achieved in all cases (100%). Postoperative complications included cerebral infarction in two patients (6.7%) and recurrent nerve palsy in one patient (3.3%). The 30-day mortality was 0%. During the median follow-up period of 14 months (6-56 months), overall survival at 12 months was 92.3% without any aneurysm-related death. Type 1 b and type 2 endoleaks were observed in one each, and no reintervention was encountered. CONCLUSIONS: Early clinical outcomes of the D-RIBS for high-risk patients with CAAs are acceptable. The gutter balloon method enables safe and reliable fenestration. Further studies and dedicated devices are warranted.

Covered Stents vs. Angioplasty for Common Iliac Artery In Stent Restenosis: A Retrospective Comparison.

OBJECTIVE: The optimal endovascular treatment for common iliac artery in stent re-stenosis has yet to be assessed. Treatment options include, among others, angioplasty alone and repeated stenting with covered stents. METHODS: This study retrospectively compared patency and target lesion revascularisation of these treatments. All patients who underwent endovascular treatment of common iliac artery in stent re-stenosis between 2007 and 2017 were included retrospectively. The primary end point was freedom from re-stenosis. Secondary endpoints were target lesion revascularisation rate (TLR) and freedom from occlusion during follow up. RESULTS: Seventy-four interventions were included, consisting of 37 angioplasties and 37 covered stent placements in 57 patients. Freedom from re-stenosis at four years was 72.6% (95% confidence interval [CI] 51.8% - 88.7%) in the covered stent group vs. 43.5% (95% CI 25.9% - 59.8%) in the percutaneous transluminal angioplasty (PTA) group (p = .003). The target lesion revascularisation (TLR) rate was 16.4% (95% CI 7.1% - 35.6%) and 43.6% (95% CI 28.0% - 63.2%) respectively (p = .020). There was no difference in freedom from occlusion; this was 90.8% (95% CI 73.9% - 97.0%) in the covered stent group and 79.1% (95% CI 58.4% - 90.3%) in the PTA group (p = .49). The difference in freedom from re-stenosis and TLR remained significant after sensitivity and multivariable analyses. CONCLUSION: Covered stents offer better outcomes for common iliac artery in stent re-stenosis than angioplasty alone.