A Single Arm Trial to Evaluate the Safety and Efficacy of the Long (> 150mm) PasseoTM-18 LuxTM Drug-coated Balloon in the Treatment of Subjects With Infrainguinal Stenotic, Restenotic or Occlusive Lesions

Обзор

This clinical trial will evaluate the study device, Passeo®-18 Lux® paclitaxel-releasing percutaneous transluminal angioplasty (PTA) balloon catheter for the treatment of new or recurring cholesterol-related blockages in the arteries of the lower leg. The device that is used in this trial has been assessed in several previous studies for safety and effectiveness. The device is already approved for use in Europe. It has a "CE mark," which means it meets the European Union's safety, health and performance standards. This trial is being done to gather additional information on how well the device works and how safe it is when used in everyday medical care with specific attention to the longer lengths of the balloon, as it comes in different sizes.

Вмешательства

• Процедура Percutaneous Transluminal Angioplasty with the use of Passeo-18 Lux DCB
  This intervention uses the Passeo-18 Lux paclitaxel-releasing percutaneous transluminal angioplasty (PTA) balloon catheter for the treatment of new or recurring cholesterol-related blockages in the arteries of the lower leg.

Первичные конечные точки

• Freedom from clinically-driven target lesion revascularization (fcd-TLR) within 12 months post-index procedure. [Срок оценки: 12-months post-index procedure]
• Freedom from Major Adverse Events (MAE) through 12 months [Срок оценки: Through 12 months post-index procedure]

Вторичные конечные точки (12)

• Successful delivery, inflation, deflation, and retrieval of the intact study device during index procedure. [Срок оценки: During index procedure]
• Restoration of target lesion with ≤30% residual stenosis in final angiogram. [Срок оценки: After index procedure]
• Number of deaths from any cause (all-cause mortality) at 1, 6, 12, 24, 36, 48, and 60 months [Срок оценки: At scheduled follow-up visits: 1, 6, 12, 24, 36, 48, and 60 months]
• Primary patency of target lesion (freedom from clinically driven target lesion revascularization [fcd-TLR] and binary restenosis) [Срок оценки: At scheduled follow-up visits: 1, 6, 12, and 24 months]
• Freedom from Clinically-driven Target Lesion Revascularization (fcd-TLR) [Срок оценки: At scheduled follow-up visits: 1, 6, 24, 36, 48, and 60 months]
• Freedom from Clinically-driven Target Vessel Revascularization (TVR) [Срок оценки: At scheduled follow-up visits: 1, 6, 12, 24, 36, 48, and 60 months]
• Freedom from major adverse events (MAE: device- or procedure-related mortality, major target limb amputation, and clinically driven TLR) [Срок оценки: At scheduled follow-up visits: 1, 6, 24, 36, 48, and 60 months]
• Amputation-free survival (AFS: alive without major amputation) [Срок оценки: At scheduled follow-up visits: 1, 6, 12, 24, 36, 48, and 60 months]
• Freedom from Major Target Limb Amputation [Срок оценки: At scheduled follow-up visits: 1, 6, 12, 24, 36, 48, and 60 months]
• Change from baseline in Rutherford classification at 1, 6, 12, and 24 months [Срок оценки: At scheduled follow-up visits: 1, 6, 12, and 24 months]
• Change from baseline in EQ-5D quality of life score at 1, 12, and 24 months [Срок оценки: At scheduled follow-up visits: 1, 12, and 24 months]
• Change from baseline in Walking Impairment Questionnaire (WIQ) score at 1, 12, and 24 months [Срок оценки: At scheduled follow-up visits: 1, 12, and 24 months]

Критерии участия

Критерии включения

• Study participant is ≥ 18 years and ≤ 99 years old
• Lesion(s) in the infrainguinal arteries:

• Lesion above the knee (ATK): Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau)
• Lesion below the knee (BTK): Target lesions involve arteries below the tibial plateau
• RVD 2-7mm
• De novo stenotic, restenotic post POBA, or occlusive lesion(s)
• Target lesion must have angiographic evidence of ≥70% stenosis
• Lesion length ≥ 3cm
• Successful crossing of the target lesion with the guide wire
• Successful predilatation, defined as residual stenosis <50% Rutherford Class 2-5
• Study participant is able to provide consent and has signed and dated the informed consent form

Критерии исключения

• Life expectancy ≤ 1 year
• Study participant is currently participating in another investigational drug or device study that has not reached its primary endpoint yet.
• Study participant is pregnant, planning to become pregnant, or father children during the course of the study.
• Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion).
• Prior bypass surgery of target vessel
• Planned major amputation of the target limb
• Thrombus in the target vessel
• Known allergy to contrast media that cannot be adequately controlled with premedication
• Study participant has a single target lesion that involves both ATK and BTK segments

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07385573 · LUX-PAD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗