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Набор скоро начнётся NCT07425171

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

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease, Long Femoropopliteal Artery Disease. Базовые параметры: 19 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

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

Критерии участия

<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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

South Korea · 1 центр
  • Ajou University Hospital — Suwon

Идентификаторы

NCT: NCT07425171 · CIP-DS1411-3

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗