NCT00542646Unknown早期 1 期
Pilot Study to Evaluate the Safety and Preliminary Efficacy of the Peritec Peritoneal Lined Stent and Delivery System
PeriTec Biosciences Ltd.1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2006年11月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Efficacy: Primary patency postprocedure and technical success Safety: Composite of major procedural adverse events
研究概览
简要总结
The occurrence of Peripheral Vascular Disease has been increasing which includes the large artery in the upper leg called Superficial Femoral Artery (SFA). The Peritoneal Lined Stent has been developed as a new method for treating narrowed area in the SFA. This research study will determine the safety and effectiveness of the Peritoneal Lined Stent in keeping th Superficial Femoral Artery open and allowing blood to flow in the leg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with claudication or ischemic rest pain(Rutherford Categories 2-4)
- •The angiogram will need to have been performed confirming superficial femoral artery short segment occlusion(<5cm first two patients and <10cm there on) or high grade(>50%)stenosis
- •Patient has a signed and dated informed consent
- •Patient has a resting ABI <0.9 or an abnormal exercise ABI if resting ABI is normal. Patients with incompressible arteries (ABI >1.2) must have TBI <0.8
- •Life expectancy greater than one year
- •The ability to comply with protocol follow up requirements and required testing
- •Angiographic lesion requirements assessed at time of procedure
- •Lesion of the superficial femoral artery with a short segment occlusion(<5cm first two patients and <10cm there on) or high grade (>50%) stenosis
- •Target lesion 1 cm below profunda/superficial femoral artery origin and 3cm above knee joint
- •Angiographic evidence of a minimum of at least one tibial with continuous artery runoff to the ankle that does not require intervention
- •Guidewire has successfully traversed lesion and is within the true lumen of the distal vessel, and successful placement of 9 french(Fr) sheath
排除标准
- •Untreated iliac artery in-flow limiting lesion
- •Significant proximal common femoral or superficial femoral artery disease above or below target lesion
- •Any previously treated superficial femoral artery lesion
- •Any previous stenting or surgery in the target vessel
- •Femoral or popliteal aneurysm
- •Non-Atherosclerotic disease resulting in occlusion (e.g. embolism, vasculitis,etc)
- •Serum creatinine >2.5 mg/dl
- •Any previously known coagulation disorder, including hypercoagulability
- •Severe medical co-morbidities or other medical condition (for example untreated coronary heart disease and congestive heart failure, severe chronic obstructive pulmonary disease, metastasis malignance, etc.)
结局指标
主要结局
Efficacy: Primary patency postprocedure and technical success Safety: Composite of major procedural adverse events
时间窗: 30 Days
次要结局
- Primary Patency Primary Assisted Patency Secondary Patency Clinical Success Major Amputations Target Vessel Revascularization Target Lesion Revascularization(3 Months Intervals except for Target Lesion Revascularization at 12 months)
研究者
研究点 (1)
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