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

Genoss

Status: Not yet enrolling

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

Study type: Observational

Funder types: Industry

Identifiers

NCT07425171

CIP-DS1411-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

<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.

Trial design

300 participants in 1 patient group

GENOSS® Peripheral DCB PTA Catheter

Description:

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