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

NCT07425171 | Not Yet Recruiting

• 1 other identifier: CIP-DS1411-3
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PTA (Percutaneous Transluminal Angioplasty); Femoropopliteal Artery Disease; Long Femoropopliteal Artery Disease

Outcome Measures

Primary Outcomes (2)

• The primary safety endpoint

  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.

  at 12 months post procedure

• The primary effectiveness endpoint

  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.

  at 12 months post procedure

Secondary Outcomes (9)

• Target lesion revascularization (TLR, %)

  at 1 month, 6 months, and 12 months post procedure

• Change in Rutherford classification

  at 1 month, 6 months, and 12 months post procedure

• Change in ABI (Ankle-brachial index) (or TBI (Toe-brachial index))

  at 1 month, 6 months, and 12 months post procedure

• Device success rate (%)

  during the procedure

• Procedural success rate (%)

  immediately post procedure

Study Arms (1)

GENOSS® Peripheral DCB PTA Catheter

Patients with long femoropopliteal artery disease treated with the GENOSS paclitaxel-coated balloon (PCB)

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with long femoropopliteal lesions who underwent percutaneous angioplasty using GENOSS PCB

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Genoss Co., Ltd.: lead

Study Sites (1)

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

MeSH Terms

Conditions

Truncus Arteriosus, Persistent

Condition Hierarchy (Ancestors)

Aortopulmonary Septal Defect; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Je Hwan Won, Radiology

CONTACT

+821092655132; wonkwak@ajou.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 20, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

KR (1)