NCT01804088已完成不适用
Clinical Investigation of the Cook Formula™ 535 Iliac Balloon-Expandable Stent
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 23
- 主要终点
- Freedom from major adverse events
研究概览
简要总结
The FORMAT Clinical Study is a clinical trial to evaluate the safety and effectiveness of the Formula™ 535 Iliac Balloon-Expandable Stent in treatment of symptomatic vascular disease of the iliac arteries.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Up to two documented common or external iliac artery lesions (one on each side), with >50% diameter stenosis, suitable for stenting
- •iliac artery reference vessel diameter of 5-10 mm
- •Rutherford Category 1, 2, 3, or 4.
排除标准
- •Less than 18 years of age
- •lesion site <10 or >100 mm in length
- •external iliac artery lesion visually estimated to be 100% occluded
- •presence of infrarenal aortic aneurysm >4 cm (treated or untreated)
- •presence of any aneurysm (treated or untreated) within target vessel
- •significant stenosis (>50%) or occlusion of inflow tract (infrarenal aortic lesions) not successfully treated before this procedure (success is measured as < 30% residual stenosis)
- •absence of at least one patent runoff vessel with ≤ 50% stenosis throughout its course (i.e., confirmed in-line patency to the level of the foot)
- •angiographically evident thrombus within the target vessel (treated or untreated)
- •lesion is in an iliac artery that has been previously stented
研究组 & 干预措施
Stent
Experimental
干预措施: Formula™ 535 Iliac Balloon-Expandable Stent (Device)
结局指标
主要结局
Freedom from major adverse events
时间窗: 9 months
次要结局
- Rate of functional status improvement based on walking impairment questionnaire(30 day, 9 month, 2 year, 3 year)
- Rate of improvement in Rutherford Category (i.e., improvement above baseline)(30 day, 9 month, 2 year, 3 year)
- Rate of acute procedure success(i.e.,vessel with <30% residual stenosis determined angiographically immediately after stent placement and no major clinical events)(Postoperative until discharge (i.e., 0 to 4 days))
- 30-day clinical success (i.e., vessel with <30% residual stenosis determined angiographically immediately after stent placement and no major clinical events)(30 day)
- Rate of technical success (i.e., successful delivery and deployment of a Formula™ 535 Iliac Balloon-Expandable Stent)(Intraoperative)
- Rate of hemodynamic success(i.e., ABI or TBI improved above baseline)(30 day, 9 month, 2 year, 3 year)
- Rate of primary patency (i.e.,the proportion of patients, over time, that have had uninterrupted patency since the initial procedure)(30 day, 9 month, 2 year, 3 year)
研究者
研究点 (23)
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