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Clinical Trial Investigating the Efficacy of the Supera Peripheral Stent System for the Treatment of the Common Femoral Artery

NCT02804113 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-01-06

No results posted yet for this study

Summary

The VMI-CFA study investigates the efficacy of the Supera Stent in the treatment of common femoral artery stenosis or occlusion. 100 patients will be included with a RF of 2 to 4. The lesion is located within the native CFA and treated with predillation prior to stenting with the Supera Peripheral Stent System. Patients will be invited for a follow-up visit at 1, 6, 12 and 24 month post procedure. The primary endpoint of the study is the primary patency at 12 months and periprocedural events up to 30 days post procedure. Secondary endpoints include technical success, primary patency rate at 1, 6 and 24 month, freedom from TLR at 1-, 6-, 12 and 24 month follow-up and clinical success at 1-, 6-, 12- and 24-month follow-up.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Supera Peripheral Stent System

Sponsors & Collaborators

  • ID3 Medical

    lead OTHER

Principal Investigators

  • Koen Deloose, MD · ID3 Medical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-25
Primary Completion
2018-06-30
Completion
2019-10-30

Countries

  • Belgium
  • France

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 NCT02804113 on ClinicalTrials.gov