NCT01042444终止不适用
Phase I Study to Demonstrate the Safety and Performance of the GARDEX™ Embolic Protection Device When Used During Percutaneous Coronary Intervention (PCI) of Saphenous Vein Graft
Gardia Medical6 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2009年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 6
- 主要终点
- The primary objective of the study is to evaluate the safety and performance of the GARDEX Protection System. The primary end point is the combined rate of major adverse events (MACE) at 30 days.
研究概览
简要总结
This is a multi center, prospective study designed to demonstrate the safety and performance of the GARDEX Embolic Protection System when used as an adjunctive device during saphenous vein graft (SVG) interventions.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anticipated patient life expectancy of at least 1 year from enrollment.
- •Patient (or their legal guardian) has provided a signed informed consent.
- •Patient is willing to comply with the protocol requirements.
- •Candidate for PCI, stenting and CABG.
- •Total CK verified to be within hospital normal limits at the time of enrollment.
- •Myocardial ischemia as evidenced by one or more of the following:
- •Diagnosis at time of enrollment of stable or unstable angina pectoris
- •Reversible 12 lead ECG changes consisted with ischemia
- •Positive function study (e.g. stress test)
- •Recent myocardial infarction (>24 hours prior to enrollment with total CK verified to be within hospital normal limits at the time of enrollment).
- •Lesions amendable to PCI.
- •Lesion(s) is located within SVG and has ≥50% and <100% stenosis (angiographic visual assessment).
- •Only single SVG graft to be treated.
- •Vessel has thrombolysis in myocardial infarction (TIMI) grade 1 or higher flow before the passage of a guidewire.
- •Reference vessel diameter where the GARDEX™ system is to be placed is ≥ 3.5mm and ≤6.0mm in diameter by angiographic visual estimation.
排除标准
- •A hypersensitivity or contraindication to heparin and bivalirum (Angiomax), aspirin, ticlopidine, clopidogrel, murine products, procedure equipment material, and a sensitivity to contrast dye which cannot be adequately pre-treated with diphenhydramine and/or steroids.
- •Myocardial infarction with documented total CK> 2 times the upper limit of normal within the past 24 hours, or currently experiencing an acute myocardial infarction.
- •A stroke or transient ischemic attach (TIA) within the past 2 months.
- •A history of bleeding diathesis or coagulopathy.
- •Major gastrointestinal (GI) bleeding within 3 months of index procedure.
- •Baseline creatinine ≥ 2.5 mg/dl.
- •A planned invasive surgical procedure within 30 days.
- •Undergone cardiac surgery within the past 60 days.
- •The lesion is in a SVG that is less than 2 months post implant.
- •Left ventricular ejection fraction < 20%
- •The lesion is an arterial conduit.
- •Anatomical exclusions that preclude placement of the GARDEX™ system per the Instruction for Use.
- •More than one SVG graft that need to be treated at the index procedure.
- •Chronic occlusion of the target lesion/severe calcification.
研究组 & 干预措施
Embolic Protection Device
Experimental
The study will involve up to 20 patients to be enrolled using the GARDEX system during clinically indicated percutaneous intervention of SVG and followed through 30 days post procedure. Patients will be enrolled at up to 3 investigative sites. The study is a prospective multi center registry with sequential enrollment of qualified patients who consent to participate and meet the eligibility criteria.
干预措施: GARDEX™ (Device)
结局指标
主要结局
The primary objective of the study is to evaluate the safety and performance of the GARDEX Protection System. The primary end point is the combined rate of major adverse events (MACE) at 30 days.
时间窗: 30 days
次要结局
- The secondary study objectives includes Device,Angiographic,Procedural and Clinical Success ,Final TIMI flow grade, Angiographically evident emboli(Device,Angiographic, Procedural Success ,Final TIMI flow grade, Angiographically evident emboli-Procedural; Clinical Success-30 days)
研究者
研究点 (6)
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