One-Year Results of GENOSS PCB Real-World Study in Femoropopliteal Artery Disease

N/AEnrolling By InvitationNCT07431437

Genoss Co., Ltd.300 enrolled

Overview

The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB by enrolling and tracking patients who underwent percutaneous transluminal angioplasty using GENOSS PCB in patients with femoropopliteal artery disease.

This prospective, multicenter, single-arm, observational study will enroll patients with femoropopliteal artery disease undergoing PTA with the GENOSS® PCB at 6 hospitals. Because this is an observational study, the number of participants will not be calculated separately, but a total of 300 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

300

Conditions

PTA (Percutaneous Transluminal Angioplasty)Femoropopliteal Artery Disease

Eligibility

Sex: ALLMin age: 19 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Korea University Guro Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: at 12 months post procedure

Secondary Outcomes

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.

Time frame: at 1 month, 6 months, and 12 months post procedure

Change in Rutherford classification

Clinical improvement as assessed by changes in target limb Rutherford classification from baseline.

Time frame: 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

Time frame: at 1 month, 6 months, and 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)

Data from ClinicalTrials.gov

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