Clinical Outcomes of GENOSS PCB for Femoropopliteal Artery Disease (GENOSS PCB)

Real-World Clinical Outcomes of GENOSS PCB (Paclitaxel-coated Balloon) for Femoropopliteal Artery Disease: A Prospective, Multicenter, Observational Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Femoropopliteal Artery Disease; PTA (Percutaneous Transluminal Angioplasty )

Detailed Description

This prospective, open-label, multicenter, observational study will enroll patients with femoropopliteal artery disease undergoing PTA with the GENOSS® PCB at 10 hospitals.

Because this is an observational study, the number of participants will not be calculated separately, but a total of 200 participants are planned to be recruited during the study period.

All patients will be followed up at 12 months postprocedure to evaluate the safety and efficacy of the paclitaxel-coated PTA balloon catheter.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 05278
    • Kyung Hee University Hospital at Gangdong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

<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. Subject with femoropopliteal artery disease who underwent percutaneous transluminal angioplasty using the GENOSS PCB.
4. At least one patent native ouflow artery to the ankle of foot, free from significant stenosis (≥50% stenosis) as confirmed by angiography.
5. 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. Women who were pregnant, breast-feeding or intended to become pregnant.
5. Subject was participating in another investigational drug or medical device study.
6. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
GENOSS® Peripheral DCB PTA Catheter; Patient treated with GENOSS PCB in the femoropopliteal artery disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Rutherford classification	Clinical improvement as assessed by changes in target limb Rutherford classification from baseline.	at 1 month, 6 months, and 12 months post procedure
Change in ABI (Ankle-brachial index) (or TBI (Toe-brachial index))	Change in ABI (ankle-brachial index) from baseline	at 1 month, 6 months, and 12 months post procedure
All-cause death (%)		at 12 months post procedure
Target vessel revascularization (TVR, %)		at 1 month, 6 months, and 12 months post procedure
Target lesion revascularization (TLR, %)	TLR is defined as any re-intervention within the target lesion due to symptoms or drop of ABI/TBI of ≥ 20% or > 0.15 when compared to post procedure baseline.	at 1 month, 6 months, and 12 months post procedure
Procedural success rate (%)	Procedural success is defined as residual stenosis of ≤ 50% by core laboratory.	immediately post procedure
Major target limb amputation (%)	Major target limb amputation is defined as any amputation above the ankle on the target limb.	at 12 months post procedure
Device success rate (%)	Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).	during the procedure
Clinical success rate (%)	Clinical success is defined as procedural success without complications (i.e. death, major target limb amputation, clinically-driven TLR) during the hospital stay post procedure.	up to 1 week

Collaborators and Investigators

• Sponsor: Genoss Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: September 30, 2025
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Heart Septal Defects; Aortopulmonary Septal Defect; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Truncus Arteriosus, Persistent
• Other Study ID Numbers: CIP-DS1411-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No