Clinical Trials in South Korea / NCT07425171
Recruiting
Observational
Safety and Effectiveness of GENOSS PCB in Patients With Long Femoropopliteal Lesion
NCT07425171 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
PTA (Percutaneous Transluminal Angioplasty)Femoropopliteal Artery DiseaseLong Femoropopliteal Artery Disease
Study 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.
Eligibility
\<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.
Primary outcome measure(s)
- The primary safety endpoint — at 12 months post procedure
The primary safety endpoint is the Major Adverse Events (MAEs)-free rate, defined as a composite of freedom from all-cause death through 1month post procedure and/or freedom from both major target limb amputation and/or clinically-driven target lesion revascularization (TLR) through 12months post procedure. - The primary effectiveness endpoint — at 12 months post procedure
The primary effectiveness endpoint is a primary patency, defined as a composite of freedom from clinically driven target lesion revascularization (CD-TLR) and freedom from binary restenosis (restenosis defined as peak systolic velocity ratio \[PSVR\] ≥ 2.4 assessed by duplex ultrasound or ≥ 50% stenosis as assessed by CT angiography) through 12months post procedure.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Ajou University Hospital | Suwon | Gyeonggi-do | Recruiting |
More Genoss Co., Ltd. trials in South Korea
Safety and Effectiveness of GENOSS® DES in Patients With Multivessel Coronary Artery Disease
Enrolling by invitation
Efficacy and Safety of GENOSS® SES in Patients With Acute Coronary Syndrome (GENOSS ACS)
Active, not recruiting
The Safety and Efficacy for In-segment Late Lumen Loss of the 'Genoss® SCB' Versus 'SeQuent® Please NEO' in Patients With Coronary ISR
Enrolling by invitation
Clinical Outcomes of GENOSS PCB for Femoropopliteal Artery Disease
Enrolling by invitation
Other trials for the same condition
Clinical Outcomes of GENOSS PCB for Femoropopliteal Artery Disease
Enrolling by invitation
One-Year Results of GENOSS PCB Real-World Study in Femoropopliteal Artery Disease
Enrolling by invitation
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07425171 on ClinicalTrials.gov ↗ ← All trials in South Korea