Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)

Официальное название

A Prospective, Multi-Center, Non-Randomized, Single-Arm Study Evaluating the Peripheral Balloon-Expandable Covered Stent System for the Treatment of Stenosis and/or Occlusive Lesions in the Common and External Iliac Arteries.

Обзор

This is a prospective, multi-center, single-arm clinical trial to evaluate the Peripheral Balloon-Expandable Covered Stent System for treating stenosis and/or occlusion in the common and external iliac arteries. The safety and effectiveness of the stent system will be compared to pre-set performance goals. All treated subjects will have follow-up visits at discharge, and at 1, 6, 12, 24, and 36 months after the procedure.

Вмешательства

• Устройство Peripheral Balloon-Expandable Covered Stent System
  The intervention in this clinical trial involves the Peripheral Balloon-Expandable Covered Stent System. This stent system is specifically designed for the treatment of stenosis and/or occlusion in the common and external iliac arteries.

Первичные конечные точки

• primary patency [Срок оценки: 12 months]

Вторичные конечные точки (2)

• Major Adverse Event [Срок оценки: 36 months]
• Secondary Patency [Срок оценки: 6, 12, 24, and 36 Months]

Критерии участия

Критерии включения

• Participants aged 18 to 80 years, regardless of sex;
• Participants diagnosed with atherosclerotic disease of the common iliac or external iliac artery;
• Participants with a Rutherford classification of 2 to 4 for the target limb;
• Participants or their legal representatives must be able to understand the study's purpose, demonstrate adequate compliance with the study protocol, and sign the informed consent form.

Критерии исключения

• Pregnant or planning to become pregnant, or breastfeeding women;
• Participants who have previously had a vascular graft implanted in the native iliac artery;
• Participants who have had a stroke or myocardial infarction within 3 months prior to enrollment;
• Participants with known uncorrectable bleeding disorders or severe coagulation abnormalities (PT or APTT ≥ 2 times the upper limit of normal; or platelet count \< 80×10\^9/L);
• Participants with serum creatinine ≥ 221 μmol/L (2.5 mg/dL) or currently undergoing dialysis;
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal;
• Severe anemia (hemoglobin level \< 60.0 g/L);
• Participants known to be allergic or intolerant to cobalt-based alloys, expanded polytetrafluoroethylene (ePTFE), aspirin, clopidogrel, heparin, rivaroxaban, paclitaxel, contrast agents, or other study materials and medications;
• Participants who have undergone vascular intervention within 30 days prior to surgery or who plan to undergo vascular intervention within 30 days following surgery;
• Participants who have received intra-arterial thrombolysis treatment in the target vessel within 14 days prior to enrollment;
• Participants with significant organ dysfunction or other severe conditions that may lead to non-compliance with the study protocol, affect data interpretation, or have a life expectancy insufficient to complete the clinical trial;
• Participants currently involved in a clinical trial of investigational drugs, biologics, or medical devices;
• Other conditions that, in the investigator's opinion, make the participant unsuitable for the clinical trial.

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

• The First Medical Centre, Chinese PLA General Hospital — Пекин

Идентификаторы

NCT: NCT06605209 · ZRD-11

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗