NCT06605209招募中不适用
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.
Zhejiang Zylox Medical Device Co., Ltd.1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年11月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- primary patency
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
primary patency
时间窗: 12 months
Primary patency of target lesion at 12-months assessed by duplex ultrasound and adjudicated by an independent core laboratory
次要结局
- Major Adverse Event(36 months)
- Secondary Patency(6, 12, 24, and 36 Months)
研究者
研究点 (1)
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