The Effectiveness of Covered Stent Viabahn and Drug-coated Balloon for Complex Femoropopliteal Artery Lesions

Официальное название

Comparison of the Effectiveness of Viabahn® Vs. Drug-Coated Balloon With/without Bail-Out Bare Metal Stent in Treating Complicated Femoropopliteal Lesions

Обзор

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

Подробное описание

This is a multicenter, observational prospective cohort clinical trial with clinical and image follow-up for two years post-procedure. Approximately 200 subjects will be enrolled into a Viabahn group (observe arm) or drug-coated balloons (DCB) group (contrast arm); Each group will include 100 patients.

All enrolled patients will be followed up for 12 and 24 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, 3,6 and 9 months.

Вмешательства

• Устройство Viabahn endoprosthesis group
  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: 12-month]
• Freedom from a composite of Major adverse events (MAEs) [Срок оценки: 12-month]

Вторичные конечные точки (7)

• Procedural success [Срок оценки: Immediately after interventional surgery]
• Primary assisted patency [Срок оценки: 12-month]
• Secondary patency [Срок оценки: 12-month]
• Clinically-driven target vessel revascularization (CD-TVR) [Срок оценки: 12-month]
• Primary sustained clinical improvement [Срок оценки: 12-month]
• Secondary sustained clinical improvement [Срок оценки: 12-month]
• Vasc quality of life score [Срок оценки: 12-month]

Критерии участия

Критерии включения

• 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 is willing to comply with specified follow-up evaluations at the specified times.
• The patient presented a score from 2 to 5 following Rutherford classification.
• The patient has a projected life expectancy of at least 24 months
• 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.

Критерии исключения

• Patients with known hypersensitivity or contraindication to any of the following medications: Contrast media, Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy
• Pregnant women or Female patients with potential childbearing
• Patients who exhibit acute intraluminal thrombus at the target lesion vessel
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
• The patient is currently participating in another investigational drug or device study that interferes with 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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06752954 · The support study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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