Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease - Post Market Clinical Trial Iliac Stent Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Number of Patients Without Rupture or Dissection of the Treated Vessel (Combined Safety and Performance Outcome)
研究概览
简要总结
This study will validate the efficacy and safety of the VESTO® Vascular Stent for treating patients with iliac peripheral arterial obstructive disease in a post-market clinical trial
详细描述
Multicenter study aimed at collecting post-market clinical data on the VESTO® vascular stent for the treatment of patients with iliac peripheral arterial occlusive disease requiring endovascular intervention. The objective of the study is to evaluate the short-term (12-month) safety and clinical performance of the Vesto® vascular stent in patients with iliac peripheral arterial occlusive disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older;
- •TASC-II aortoiliac lesion classification of modified class A, B, C, or D;
- •Rutherford classification score of 2 to 5;
- •Access site compatibility with the device delivery system;
- •Compliance with the device's instructions for use (IFU);
- •Patient availability for appropriate follow-up times for the duration of the study;
- •Patient informed about the nature of the study, agreeing to its provisions, and signing the informed consent form.
排除标准
- •Known hypersensitivity to heparin, contrast media, or stent components;
- •Patient with blood dyscrasia;
- •Pregnant or breastfeeding women;
- •Patient currently participating in an investigational drug or device study;
- •Patient undergoing chemotherapy or radiation therapy;
- •Patient with a stent or graft located in the target limb;
- •Patient who underwent angioplasty or bypass surgery within 30 days prior to inclusion in this study;
- •Patient with a life expectancy of less than 12 months;
- •Inability to undergo dual antiplatelet therapy (DAPT)
结局指标
主要结局
Number of Patients Without Rupture or Dissection of the Treated Vessel (Combined Safety and Performance Outcome)
时间窗: 30 days post index procedure
Absence of rupture or dissection of the treated vessel within 30 days after the procedure
Incidence of Device-Related Serious Adverse Events (Device Safety)
时间窗: 30 days post-index procedure
Absence of major serious adverse events occurring within 30 days after the index procedure, defined as device- or procedure-related death, acute myocardial infarction (AMI), or above-the-metatarsal amputation in the treated leg due to a vascular event
Number of Patients with Technical Success (Device Performance)
时间窗: Intraoperative
Technical success with the absence of serious adverse events related to the device
次要结局
- Primary Patency Rate(30 days post index procedure)
- Rate of Target Vessel Patency(3, 6, 9, and 12 months)
- Limb Salvage Rate(30 days, 6, 9, and 12 months)
- Number of Patients with Clinical Success(30 days, 3, 6, 9, and 12 months)
- Incidence of Adverse Events(30 days, 3, 6, 9, and 12 months)
- Rate of Technical Success(Intraoperative)
- Rate of Procedural Success(30 days post index procedure)
- Conversion Rate to Open Surgery(Intraoperative)
- Need for Endovascular Reintervention at the Target Lesion(30 days, 3, 6, 9, and 12 months)