UnknownNot Applicable

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

Austria86 participantsStarted 2015-10-01

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject (or their legal guardian) has read, understood and provided written informed consent, which has been reviewed and approved by the Institutional Review Board.
. At least 18 years of age.
. Male, infertile female or female participants of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7-days prior to study procedure.
. Projected life expectancy of greater than two years.
. The ability to comply with protocol follow-up requirements and required testing.
. Lifestyle-limiting claudication or CLI (meeting angiographic entry criteria) affecting a lower extremity (Rutherford stages 2-5). Patients with Rutherford stage 2 are only eligible after unsuccessful conventional and/or medicamentous therapy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Amount of in-stent restenosis

Timeframe: one and two years post-procedure

Trial details

NCT IDNCT03097679

SponsorMedical University of Vienna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07-31

View on ClinicalTrials.gov More Stent Restenosis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject (or their legal guardian) has read, understood and provided written informed consent, which has been reviewed and approved by the Institutional Review Board.
. At least 18 years of age.
. Male, infertile female or female participants of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7-days prior to study procedure.
. Projected life expectancy of greater than two years.
. The ability to comply with protocol follow-up requirements and required testing.
. Lifestyle-limiting claudication or CLI (meeting angiographic entry criteria) affecting a lower extremity (Rutherford stages 2-5). Patients with Rutherford stage 2 are only eligible after unsuccessful conventional and/or medicamentous therapy.

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria