NCT01273350Unknown不适用
Physician I.D.E. G#040160; Low Risk Carotid Stenting Study Using Bivalirudin at PinnacleHealth Hospitals and Holy Spirit Hospital
SPSI d.b.a Capital Cardiovascular Associates2 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2004年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Major adverse events, defined as death, ipsilateral stroke, myocardial infarction,(Q and non-Q wave) or major bleeding as 30 days post procedure
研究概览
简要总结
Prospective, non-randomized, single-center cohort study treating internal carotid artery stenosis using the Xact Carotid Artery Stent and emboshield distal protection system in conjunction with bivalirudin as the procedural anticoagulation
详细描述
Primary objective is to evaluate the safety and feasibility of the XACT stent and emboshield with Angiomax as the procedural anticoagulant.
Primary safety endpoint is the occurrence of Major Adverse Events, defined as death, myocardial infarction (Q or non Q wave), and from target revascularization at one year
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
- 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
- •Patient (male or non-pregnant female)must be > than or= 18
- •Qualifying non-invasive test (ultrasound or MRA) was performed less than 60 days prior to study entry. Carotid duplex study revealed:
- •Stenosis > or = to 50% in symptomatic patients
- •Stenosis > or = to 60% in asymptomatic patients
- •Target lesion may be in the common or internal carotid artery and is amenable to treatment with angioplasty and stenting
- •Patients taking warfarin may be included if their dosage is reduced before the procedure to result in an INR of 1.5 or less and a Prothrombin time of 15 seconds. Warfarin may be started after the procedure.
- •Female patients of childbearing potential must have a documented negative pregnancy test during index hospitalization
- •Patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local institutional review board or medical ethics committee
排除标准
- •(Patients will be excluded from the study if ANY of the following conditions are present)
- •There is total occlusion of the target carotid artery treatment site.
- •The patient has an allergy or contraindication to aspirin, ticlopidine, clopidogrel, bivalirudin, nickel, titanium, or a sensitivity to contrast media, which cannot adequately pre-medicated.
- •The subject has a platlet count< 100,000 cells/mm3 or 700,000 cells/mm3 or a WBC of < 3,000 cells/mm
- •Stroke within 7 days prior to the procedure
- •NIH stroke score > or = to 15 within 7 days prior to the procedure
- •The patient has experienced a significant GI bleed within 6 months prior to study procedure
- •The patient has active internal bleeding
- •The patient has had major surgery or serious trauma within 6 weeks before enrollment
- •The patient has excessive peripheral vascular disease that precludes safe sheath insertion
- •The patient has had an intracranial hemorrhage, hemorrhagic stroke, major stroke or any stroke within one week of index procedure
- •The patient has concurrent emboligenic cardiovascular disease not adequately treated with anticoagulant therapy
- •The patient is on renal dialysis
- •The patient has had low molecular weight heparin (LMWH) administered within 8 hours or less, prior to the procedure
- •Severe hypertension not adequately controlled by antihypertensive therapy at the time of study entry(BP> 180/110mmHG)
- •The patient is unable or unwilling to cooperate with the study follow-up procedures
结局指标
主要结局
Major adverse events, defined as death, ipsilateral stroke, myocardial infarction,(Q and non-Q wave) or major bleeding as 30 days post procedure
时间窗: 30 days
次要结局
- Freedom from vascular complications ;Acute success defined by lesion, device, and procedural success; Freedom from any death, stroke MI (Q, non-Q wave), and from target lesion revascularization at one year(1 Year)
研究者
Rajesh Dave, MD
Chief Medical Executive Holy Spirit Cardiovascular Institute
SPSI d.b.a Capital Cardiovascular Associates
研究点 (2)
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