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Self-expanding Nitinol Stents of High vs. Low Chronic Outward Force in De-novo Femoropopliteal Occlusive Arterial Lesions

NCT03097679 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2020-02-20

No results posted yet for this study

Summary

The objective of the BIOFLEX-COF trial is to investigate differences in formation of intimal hyperplasia at one and two years after implantation of nitinol-stents with high vs. low COF in de-novo femoropopliteal occlusive lesions in patients with symptomatic peripheral arterial disease.

The BIOFLEX-COF trial is a prospective, randomized controlled trial. 80 subjects will be enrolled and randomly assigned to either a high COF group (LifeStent Vascular Stent) or low COF group (Pulsar).

Conditions

  • Stent Restenosis
  • Intimal Hyperplasia

Interventions

DEVICE

Pulsar Stent

Percutane transluminal stent angioplasty with a Pulsar Stent of the superficial femoral artery for the treatment of peripheral arterial occlusive disease.

DEVICE

LifeStent Flexstar Vascular Stent

Percutane transluminal stent angioplasty with a LifeStent Flexstar Vascular Stent of the superficial femoral artery for the treatment of peripheral arterial occlusive disease.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-01
Primary Completion
2019-07-31
Completion
2020-12-31

Countries

  • Austria

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 NCT03097679 on ClinicalTrials.gov