Long femoropopliteal artery disease: GENOSS paclitaxel-coated balloon safety and effectiveness after PTA

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, single-arm observational study enrolling about 300 adults treated with GENOSS PCB during percutaneous transluminal angioplasty for long femoropopliteal lesions. Participants will be followed for 12 months to monitor safety and the primary outcomes of major adverse event-free rate and primary patency. The study collects real-world data on long-term outcomes in a broad patient group and does not include a comparator group. Eligibility includes adults 19 or older with Rutherford category 2–5, 70% or greater stenosis, lesions ≥150 mm, and vessel diameter 4–7 mm, while excluding paclitaxel allergies, antiplatelet contraindications, and limited life expectancy. The lead sponsor is Genoss Co., Ltd., with Ajou University Hospital as the participating site.

Why it matters

Who can join: the full rules

\<Inclusion criteria\>

Enrollment in the study was limited to patients who met the following inclusion criteria:

1. Subject was ≥19 years of age.
2. Subject had target limb Rutherford classification 2, 3, 4 or 5.
3. Subjects with a stenosis of 70% or greater in the femoropopliteal artery.
4. 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.)
5. Subjects with a reference vessel diameter of ≥4 mm but ≤7 mm.
6. Subject provided written informed consent and was willing to comply with the study follow-up requirements.

\<Exclusion criteria\>

Patients were not permitted to enroll in the study if they met any of the following exclusion criteria:

1. Subjects was allergic to paclitaxel.
2. Subjects with contraindications or hypersensitivity to antiplatelet therapy.
3. Subject had life expectancy of less than 2 years.
4. Those who have undergone vascular surgery on the target lesion within the past 6 weeks.
5. Those who have in-stent restenosis (ISR) on the target lesion.
6. Those who have non-arteriosclerotic vascular disease, such as an aneurysm or vasculitis, on the target lesion.
7. Women who were pregnant, breast-feeding or intended to become pregnant.
8. Those who cannot perform pre-dilatation or who fail to apply the device, making it difficult to apply the device.
9. Those who have a Grade D or higher vascular dissection restricting blood flow after pre-dilatation or who require stent placement.
10. Those who, in the investigator's judgment, are not suitable for this study or may increase the risks associated with participation in the study.

Where it's running

• Ajou University Hospital
  Suwon, Gyeonggi-do, South Korea Recruiting

Study contacts

• Study coordinator: Je Hwan Won, Radiology
• Email: wonkwak@ajou.ac.kr
• Phone: +821092655132

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.