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A Study Evaluating the Endovascular Treatment of Subjects with Stenotic or Restenotic Lesions of the Common Femoral Artery with the Supera Vascular Mimetic Implant Compared to Surgical Common Femoral Artery Endarterectomy

NCT04349657 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2024-10-16

No results posted yet for this study

Summary

The SUPERSURG RCT trial investigates the efficacy and safety of the endovascular treatment of stenosis or restenosis in the common femoral artery (CFA) of patients presenting with Rutherford classification 2,3 or 4 with a Supera Vascular Mimetic Implant of Abbott, compared to classic surgical common femoral artery endarterectomy. The Supera Vascular Mimetic Implant has an interwoven design and has a high crush resistance and is, when correctly implanted, an ideal stent to treat eccentric calcified plaques in the CFA.

An expected total of 143 patients will be treated with the Vascular Mimetic Implant of Abbott and compared to a control group of another 143 patients that will be treated with classic surgical endarterectomy of the common femoral artery. Assignment to the treatment groups will be at random.

Patients will be invited for a follow-up visit at 1, 6, 12, 24 and 36 months post-procedure.

The primary efficacy endpoint is defined as follows: freedom from clinically-driven target lesion revascularization and binary restenosis at 12 months. The primary safety endpoint is defined as follows: a composite of overall death, cardiac, pulmonary, renal complications, sepsis, target lesion revascularisation and wound related complications through 30 days post-index procedure.

The secondary endpoints are defined as technical success, primary patency in the deep femoral artery, primary patency in the target lesion, target lesion revascularisation, target vessel revascularisation, binary restenosis, duration of initial hospital stay, sustained clinical improvement, change of walking impairment questionnaire score from baseline, change in target limb Rutherford classification, change in target limb ABI/TBI from baseline, all cause death, thrombosis at the target lesion through 6, 12, 24 and 36 months post-procedure.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Supera Peripheral Stent System treatment group

Percutaneous endovascular stenting with the Supera Peripheral Stent System

PROCEDURE

Endarterectomy treatment group

Surgical treatment through endarterectomy

Sponsors & Collaborators

  • ID3 Medical

    lead OTHER

Principal Investigators

  • Koen Deloose, MD · A.Z. Sint-Blasius

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-05
Primary Completion
2026-09-30
Completion
2028-09-30

Countries

  • Belgium
  • Netherlands
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04349657 on ClinicalTrials.gov