Not Yet RecruitingNot Applicable

Safety and Effectiveness of GENOSS PCB in Patients With Long Femoropopliteal Lesion

South Korea300 participantsStarted 2026-02-24

Plain-language summary

The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB in patients with long femoropopliteal lesions who underwent percutaneous transluminal angioplasty using GENOSS PCB.

Who can participate

Age range

19 Years – 85 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 was ≥19 years of age.
. Subject had target limb Rutherford classification 2, 3, 4 or 5.
. Subjects with a stenosis of 70% or greater in the femoropopliteal artery.
. Subjects with a stenotic or occlusive lesion measuring ≥150 mm in total length. (Multiple adjacent lesions separated by less than 3 cm from angiographically healthy segments are treated as a single lesion.)
. Subjects with a reference vessel diameter of ≥4 mm but ≤7 mm.
. Subject provided written informed consent and was willing to comply with the study follow-up requirements.

Exclusion criteria

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

The primary safety endpoint

Timeframe: at 12 months post procedure

The primary effectiveness endpoint

Timeframe: at 12 months post procedure

Trial details

NCT IDNCT07425171

SponsorGenoss Co., Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-12-31

Contact for this trial

Je Hwan Won, Radiology

+821092655132 wonkwak@ajou.ac.kr

View on ClinicalTrials.gov More PTA (Percutaneous Transluminal Angioplasty) trials