The Efficacy of Heparin-boned Viabahn Endoprosthesis and Paclitaxel-coated Balloons for Complex Femoropopliteal Lesions

Официальное название

Comparing the Efficacy of Heparin-boned Viabahn@ Endoprosthesis and Paclitaxel-coated Balloons for Endovascular Treatment of Complex Femoropopliteal Lesions

Обзор

The purpose of this study is to evaluate the effectiveness of the Viabahn endoprosthesis for treating long femoropopliteal lesions (stenosis ≥ 25cm, occlusion ≥ 15cm) or recurrent in-stent restenosis compared to drug-coated balloons (DCB) with or without a bailout bare nitinol stent.

Подробное описание

This is a multicenter, prospective, 1:1 randomized clinical trial with clinical and image follow-up for two years post-procedure. Approximately 60 subjects will be enrolled and randomized into a Viabahn preferred group (study arm) or drug-coated balloons (DCB) group (control arm); Each group will include 30 patients. All enrolled patients will be followed up for 12 months to assess the incidence of restenosis by duplex ultrasound and major adverse events. Follow-up visits occur at 12 and 24 months, as well as telephone visits after 1, 6, 9 and 24 months.

Вмешательства

• Устройство Viabahn endoprosthesis group
  Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by Viabahn endoprosthesis.
• Устройство Drug-coated balloon group
  Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by drug-coated balloon.

Первичные конечные точки

• Primary patency [Срок оценки: 24-month]
• Freedom from a composite of Major adverse events (MAEs) [Срок оценки: 24-month]

Вторичные конечные точки (7)

• Procedural success [Срок оценки: Immediately after interventional surgery]
• Primary assisted patency [Срок оценки: 24-month]
• Secondary patency [Срок оценки: 24-month]
• Clinically-driven target vessel revascularization (CD-TVR) [Срок оценки: 24-month]
• Primary sustained clinical improvement [Срок оценки: 24-month]
• Secondary sustained clinical improvement [Срок оценки: 24-month]
• Vasc quality of life score [Срок оценки: 24-month]

Критерии участия

Критерии включения

• The patient presented a score from 2 to 5 following Rutherford classification.
• The patient is willing to comply with specified follow-up evaluations at the specified times.
• The patient is ≥ 18 years old.
• Patient understands the nature of the procedure and provides written informed consent before enrolment in the study
• The patient has a projected life expectancy of at least 24 months
• Before enrolment, the guidewire has crossed the target lesion
• Subject has a de novo or restenotic lesion with ≥ 70% stenosis in femoropopliteal artery, and for de novo lesion, the total lesion length ≥ 25cm, or chronic total occlusion (CTO) length ≥15cm.
• There is angiographic evidence of patent infrageniculate popliteal artery and at least one distal runoff to the foot.
• Origin and proximal 1 cm of Superficial Femoral Artery (SFA) are patent.
• Reference vessel diameter (RVD) ≥ 4 mm by visual estimation.

Критерии исключения

• Previous bypass surgery or stenting in the target vessel
• Patients who exhibit acute intraluminal thrombus at the target lesion vessel
• Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy
• Pregnant women or Female patients with potential childbearing
• Use of thrombectomy, atherectomy, or laser devices during the procedure
• Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)
• The patient is currently participating in another investigational drug or device study that interferes with the study
• Significant renal dysfunction (Serum creatinine >3.0mg/dl)
• Patient with Known allergy to contrast media
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
• Femoral or popliteal aneurysm.
• Current peritoneal or hemodialysis.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Renji Hospital — Шанхай

Идентификаторы

NCT: NCT06124755 · The Virtue study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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