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

Safety and Effectiveness of GENOSS PCB (Paclitaxel-coated Balloon) in Patients With Long Femoropopliteal Lesion: A Prospective, Multicenter, Observational Study (GENOSS-PCB Long)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Femoropopliteal Artery Disease; PTA (Percutaneous Transluminal Angioplasty); Long Femoropopliteal Artery Disease

Detailed Description

This is a prospective, multicenter, single-arm, observational study designed to evaluate the long-term safety and effectiveness of the GENOSS paclitaxel-coated balloon (PCB) in patients with long femoropopliteal artery lesions treated with percutaneous transluminal angioplasty (PTA).

The study will enroll patients who undergo PTA using the GENOSS PCB at 4 hospitals. Approximately 300 patients are planned to be enrolled during the study period.

All enrolled patients will be followed for 12 months after the index procedure to assess the long-term safety and effectiveness of the GENOSS PCB. Additionally, the primary endpoints, major adverse event-free rate and primary patency, will be assessed during follow-up.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Je Hwan Won, Radiology; Phone Number: +821092655132; Email: wonkwak@ajou.ac.kr

Study Locations

• South Korea
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, South Korea, 16499
      • Ajou University Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

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

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. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
GENOSS® Peripheral DCB PTA Catheter; Patients with long femoropopliteal artery disease treated with the GENOSS paclitaxel-coated balloon (PCB)

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 (Estimated): February 24, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

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-DS1411-3

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