Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Observational

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

NCT07425171 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2026-04-13
Last updated
2026-09-11

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

Sex
ALL
Min age
19 Years
Max age
85 Years
Healthy volunteers
No
\<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)

FacilityCityRegionStatus
Ajou University Hospital Suwon Gyeonggi-do Recruiting
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