Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions

Официальное название

Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions: the SAFARI Study

Обзор

This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions.

Подробное описание

One hundred twenty patients with lesion lengths longer than 15 cm will be included. Patients will be invited for a follow-up visit at 1, 6, 12, and 24-month post-procedure. The primary effectiveness endpoint of the study is the primary patency at 12 months. The primary safety endpoint is freedom of major adverse events (MAEs) at 12 months. Secondary endpoints include acute procedure success rate; primary patency rate at 1, 6, and 24 months; freedom from TLR at 1-, 6-, 12, and 24-month follow-up; primary and secondary sustained clinical improvements at 1-, 6-, 12- and 24-month follow-up; Freedom of MAEs at 1-, 6-,12- and 24- month follow-up; change of quality of life at 1-, 6-,12- and 24- month follow-up.

Вмешательства

• Устройство Smart flex stent
  Smart flex stent will be used for femoropopliteal occlusive lesions.

Первичные конечные точки

• Primary patency [Срок оценки: 12-month]
• Freedom of major adverse events (MAEs) [Срок оценки: 12-month]

Вторичные конечные точки (6)

• Acute procedure success [Срок оценки: 72-hour within procedure]
• Primary patency [Срок оценки: 24-month]
• Freedom from clinically directed target lesion revascularization [Срок оценки: 24-month]
• Freedom of major adverse events (MAEs) [Срок оценки: 24-month]
• Primary 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
• Target lesion length ≧150mm by angiographic estimation
• Stenosis > 50% or occlusion in the femoropopliteal artery
• There is angiographic evidence of patent distal popliteal artery and at least one distal runoff to the foot

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 has not reached the primary endpoint.
• Significant renal dysfunction (Serum creatinine >2.0mg/dl)
• Patient with Known allergy to contrast media

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

Китай · 1 центр

• Renji Hospital — Шанхай

Идентификаторы

NCT: NCT05894863 · The SAFARI Study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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