Clinical Outcomes of GENOSS PCB for Femoropopliteal Artery Disease

NCT07399080 | Enrolling By Invitation

• 1 other identifier: CIP-DS1411-1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PTA (Percutaneous Transluminal Angioplasty ); 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

Patient treated with GENOSS PCB in the femoropopliteal artery disease

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

Patient with percutaneous transluminal angioplasty with GENOSS® PCB in the femoropopliteal artery disease

You may qualify if:

• 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.

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.
• Women who were pregnant, breast-feeding or intended to become pregnant.
• Subject was participating in another investigational drug or medical device study.
• 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.

Sponsors & Collaborators

• Genoss Co., Ltd.: lead

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, 05278, 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: February 10, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 18, 2026

Record last verified: 2025-08

Locations

KR (1)