Stent placement in the superficial femoral and proximal popliteal arteries with the innova self‐expanding bare metal stent system

Powell, Richard J.; Jaff, Michael R.; Schröe, Herman; Benko, Andrew; Diaz‐Cartelle, Juan; Müller‐Hülsbeck, Stefan

doi:10.1002/ccd.26976

Cited by 16 publications

(9 citation statements)

References 41 publications

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“…For the primary effectiveness assessment, the observed primary patency rate was compared with a 60% performance goal determined by adding 10% (estimated drug effect) to the historical patency rate for long lengths of the bare nitinol stent platform. 11 No hypothesis testing was performed for the primary safety outcome, but the MAE-free rate was expected to be similar to the 95% reported at 12 months for the IMPERIAL randomized study. 8 Categorical variables are reported as counts and percentages and continuous variables are reported as mean ± standard deviation.…”

Section: Discussionmentioning

confidence: 98%

Effectiveness and Safety of a Paclitaxel-Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm: One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of the Eluvia Drug-Eluting Stent

et al. 2020

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Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disease in patients with long lesions. Materials and Methods: The global IMPERIAL Long Lesion substudy ( ClinicalTrials.gov identifier NCT02574481) is a prospective, single-arm, multicenter trial of the Eluvia Drug-Eluting Vascular Stent for treating femoropopliteal lesions >140 mm and ≤190 mm in length. Fifty patients (mean age 68.2 years; 32 men) with long lesions (mean length 162.8±34.7 mm) were enrolled; 20 patients had diabetes. Fourteen of the lesions were severely calcified and 16 were occluded. Primary patency (duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically-driven target lesion revascularization or bypass of the target lesion) and major adverse events [30-day all-cause death and 1-year target limb major amputation or target lesion revascularization (TLR)] were assessed at 12 months. Results: At 12 months, no deaths, target limb amputations, or stent thrombosis had occurred. The Kaplan-Meier estimate of primary patency was 91.0% (95% CI 82.5% to 99.6%). The MAE-free rate at 12 months was 93.5% due to 3 clinically-driven TLRs. The corresponding Kaplan-Meier estimate of freedom from TLR was 93.9% (95% CI 87.2% to 100%). Conclusion: The IMPERIAL Long Lesion substudy demonstrated excellent patency and safety through 1 year among patients with long femoropopliteal occlusive disease treated with the Eluvia stent.

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Section: Discussionmentioning

confidence: 98%

Effectiveness and Safety of a Paclitaxel-Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm: One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of the Eluvia Drug-Eluting Stent

et al. 2020

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“…[37][38][39][40][41][42][43][44][45][46][47][48][49][50][51][52][53][54][55] In selected bare metal stent trials (Table 5), the antithrombotic regimen is not described or elaborated on. [56][57][58][59] The SuperNova trial reported the percentage of patients on any antiplatelet at various points in follow-up but did not make any distinction between SAPT and DAPT. Covered stent trials (Table 6) used DAPT for 6 to 12 months postintervention but similar to other device trials have not uniformly reported precise antithrombotic regimens at various points of follow-up.…”

Section: Antithrombotic Treatment In Device Trialsmentioning

confidence: 99%

Antithrombotic Therapy After Revascularization in Patients With Peripheral Arterial Disease: What Is Here, What Is Next

Amer

Joshi

et al. 2019

Vasc Endovascular Surg

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Objective: The optimal antithrombotic regimen in peripheral arterial disease (PAD) is not known, leading to significant variations in antithrombotic treatment protocols in randomized trials and clinical practice. In device trials, antithrombotic regimens in patients receiving peripheral vascular interventions have not been clearly reported on. This review summarizes and discusses the most recent evidence on this topic to provide a potential guide to clinical practice. Methods: A search of the literature was done for publications that reported outcomes of major PAD device trials. Reported outcomes and various antithrombotic regimens were studied. Results: Use of antithrombotic therapy varied significantly between various device trials. Reporting of antithrombotic regimens at the time of follow-up is lacking. Conclusion: Outcome data on optimal antithrombotic regimens are presently lacking largely due to the significant heterogeneity and underreporting of antithrombotic regimens at follow-up among prior clinical trials. Standardization and reporting of precise antithrombotic regimens at various points of follow-up in device trials of patients with PAD should be attempted so as to minimize differences in treatment patterns when evaluating new devices.

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“…For example, the LifeStent RESILIENT study 15 reported an 81.3% 12-month primary patency with a mean 7.1-cm lesion length. Corresponding data in the SUPERA SUPERB study 16 (78.9% and a mean 7.8-cm length) and Innova SuperNOVA study 17 (66.4% in a mean 9.1-cm length) demonstrate well the decreasing primary patency rates that accompany increasing lesion length in the femoropopliteal segment.…”

Section: Discussionmentioning

confidence: 55%

Prospective Evaluation of the TIGRIS Vascular Stent Within a Modern Treatment Algorithm

et al. 2019

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Purpose: To prospectively evaluate the safety and efficacy of the TIGRIS Vascular Stent in the superficial femoral artery (SFA) and proximal popliteal artery within a treatment algorithm that reserved stent usage for more challenging patients. Materials and Methods: This prospective, single-center study enrolled 97 patients (mean age 68.7 years; 66 men) who were treated for 100 de novo or nonstented restenotic femoropopliteal lesions (≥70% stenosis) and had recoil or dissection after plain balloon predilation. The average lesion length was 5.6±2.3 cm (maximum 8 cm per protocol). The composite primary efficacy outcome was 12-month primary patency, defined as a peak systolic velocity ratio ≤2.5 at the stented target lesion on duplex ultrasound, and no clinically-driven reintervention within the stented segment. The primary safety outcome was freedom from device- and procedure-related target vessel revascularization, target limb major amputation (above the metatarsals), or death through 30 days. Secondary outcomes included secondary patency, clinically-driven target lesion revascularization (TLR), Rutherford category change relative to baseline, and binary restenosis of the target lesion. Results: All devices were successfully implanted with no device-related complications at the time of implant or within the 30-day postimplant window. The average stented length was 7.0±2.5 cm; no stent elongation was observed during deployment. One patient was lost to follow-up before 12 months and another died of an unrelated cause, leaving 95 patients (98 lesions) available for 12-month follow-up and 77 patients/lesions for the 24-month preliminary analysis. The binary primary and secondary patency rates at 12 months were 92.9% and 100%. The binary freedom from TLR was 94.9%. At 24 months, the Kaplan-Meier estimate of primary patency was 90.0%. Conclusion: This prospective study demonstrated that the TIGRIS Vascular Stent is a safe and effective device in a modern treatment algorithm that reserved bare stent use for postangioplasty dissection or recoil in distal femoropopliteal arteries.

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Stent placement in the superficial femoral and proximal popliteal arteries with the innova self‐expanding bare metal stent system

Abstract: In the SuperNOVA study, the Innova Stent System demonstrated an excellent safety profile and acceptable clinical outcomes despite the challenging anatomical characteristics of the lesions. © 2017 Wiley Periodicals, Inc.

Cited by 16 publications

References 41 publications

Effectiveness and Safety of a Paclitaxel-Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm: One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of the Eluvia Drug-Eluting Stent

Effectiveness and Safety of a Paclitaxel-Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm: One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of the Eluvia Drug-Eluting Stent

Antithrombotic Therapy After Revascularization in Patients With Peripheral Arterial Disease: What Is Here, What Is Next

Prospective Evaluation of the TIGRIS Vascular Stent Within a Modern Treatment Algorithm

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