Clinical Outcomes of GENOSS PCB for Femoropopliteal Artery Disease (NCT07399080) | Clinical Trial Compass
By InvitationNot Applicable
Clinical Outcomes of GENOSS PCB for Femoropopliteal Artery Disease
South Korea200 participantsStarted 2025-07-01
Plain-language summary
The GENOSS PCB study aims to evaluate the safety and efficacy of a Paclitaxel-coated PTA Balloon Catheter(GENOSS® PCB) in patients with the femoropopliteal artery disease.
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.
. Subject with femoropopliteal artery disease who underwent percutaneous transluminal angioplasty using the GENOSS PCB.
. At least one patent native ouflow artery to the ankle of foot, free from significant stenosis (≥50% stenosis) as confirmed by angiography.
. Subject provided written informed consent and was willing to comply with the study follow-up requirements.
Exclusion criteria
. Subjects was allergic to paclitaxel.
. Subjects with contraindications or hypersensitivity to antiplatelet therapy.
. Subject had life expectancy of less than 2 years.
. Women who were pregnant, breast-feeding or intended to become pregnant.
. Subject was participating in another investigational drug or medical device study.
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.
. Subject was unwilling or unable to comply with procedures specified in the protocol or had difficulty or inability to return for follow-up visits as specified by the protocol.