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Not yet recruiting NCT07425171

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

— Observational PTA (Percutaneous Transluminal Angioplasty) Femoropopliteal Artery Disease Long Femoropopliteal Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease, Long Femoropopliteal Artery Disease. Basic parameters: 19 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Primary outcome measures

  • The primary safety endpoint [Time frame: at 12 months post procedure]
  • The primary effectiveness endpoint [Time frame: at 12 months post procedure]
Secondary outcome measures (9)
  • Target lesion revascularization (TLR, %) [Time frame: at 1 month, 6 months, and 12 months post procedure]
  • Change in Rutherford classification [Time frame: at 1 month, 6 months, and 12 months post procedure]
  • Change in ABI (Ankle-brachial index) (or TBI (Toe-brachial index)) [Time frame: at 1 month, 6 months, and 12 months post procedure]
  • Device success rate (%) [Time frame: during the procedure]
  • Procedural success rate (%) [Time frame: immediately post procedure]
  • Clinical success rate (%) [Time frame: up to 1 week]
  • All-cause death (%) [Time frame: at 12 months post procedure]
  • Target vessel revascularization (TVR, %) [Time frame: at 1 month, 6 months, and 12 months post procedure]
  • Major target limb amputation (%) [Time frame: at 12 months post procedure]

Eligibility criteria

<Inclusion criteria>

Enrollment in the study was limited to patients who met the following inclusion criteria:

  • Subject was ≥19 years of age.
  • Subject had target limb Rutherford classification 2, 3, 4 or 5.
  • Subjects with a stenosis of 70% or greater in the femoropopliteal artery.
  • 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.)
  • Subjects with a reference vessel diameter of ≥4 mm but ≤7 mm.
  • 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:

  • Subjects was allergic to paclitaxel.
  • Subjects with contraindications or hypersensitivity to antiplatelet therapy.
  • Subject had life expectancy of less than 2 years.
  • Those who have undergone vascular surgery on the target lesion within the past 6 weeks.
  • Those who have in-stent restenosis (ISR) on the target lesion.
  • Those who have non-arteriosclerotic vascular disease, such as an aneurysm or vasculitis, on the target lesion.
  • Women who were pregnant, breast-feeding or intended to become pregnant.
  • Those who cannot perform pre-dilatation or who fail to apply the device, making it difficult to apply the device.
  • Those who have a Grade D or higher vascular dissection restricting blood flow after pre-dilatation or who require stent placement.
  • Those who, in the investigator's judgment, are not suitable for this study or may increase the risks associated with participation in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Ajou University Hospital — Suwon

Identifiers

NCT: NCT07425171 · CIP-DS1411-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗