NCT03957473已完成不适用
CHEETAH: A Prospective, Multicenter Study to Evaluate the Safety and Performance of the CAT RX Aspiration Catheter in Patients With a High Thrombus Burden Acute Coronary Vessel Occlusion
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 25
- 主要终点
- Composite of:
研究概览
简要总结
The objective of this study is to demonstrate the safety and performance of the Indigo Aspiration System using the CAT RX aspiration catheter in a population presenting with acute high thrombus burden coronary vessel occlusion who are referred for Percutaneous Coronary Intervention (PCI).
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
- •Patient age ≥ 18 years
- •Patient presents to treating facility within 12 hours of symptom onset
- •High thrombus burden at coronary angiography, defined as TIMI thrombus grade 4 or 5 by physician visual estimate after the guidewire crosses the target lesion
- •Frontline treatment with the Indigo® Aspiration System using the CAT RX Aspiration Catheter, prior to standard of care PCI
- •Target lesion is located in a native coronary artery
- •Informed consent is obtained from either patient or legally authorized representative (LAR)
排除标准
- •New onset of stroke symptoms and NIHSS > 2, prior to index procedure
- •Treatment with fibrinolytic therapy for index coronary vessel occlusion
- •Life expectancy less than 6 months due to any comorbidities
- •Patient is unwilling or unable to comply with protocol follow up schedule and/or based on the Investigator's judgment the patient is not a good study candidate
- •Participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.
- •Patient is pregnant
结局指标
主要结局
Composite of:
时间窗: 30 days
Cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association Class IV heart failure
次要结局
- Final TIMI Thrombus Grade(Procedure)
- All-Cause Mortality(180 Days)
- Cardiogenic Shock(180 Days)
- Final TIMI Flow Grade(Procedure)
- Major Bleeding(30 Days)
- Stroke(30 Days)
- Recurrent MI(180 Days)
- Myocardial Blush Grade(Procedure)
- Class IV Heart Failure(180 Days)
- Incident of Device Related SAEs(180 Days)
- Distal Embolization Rate(Procedure)
- Stent Thrombosis(180 Days)
- Cardiovascular Death(180 Days)
研究者
研究点 (25)
Loading locations...
相似试验
已完成
不适用
Clinical Investigation of the Cheetah System For The Correction of Myopia With and Without AstigmatismMyopiaAstigmatismNCT04200898Johnson & Johnson Surgical Vision, Inc.286
进行中（未招募）
不适用
BOLT-DVT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein ThrombosisDeep Vein ThrombosisDVTNCT05003843Penumbra Inc.229
已完成
不适用
Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary EmbolismPulmonary EmbolismNCT03218566Penumbra Inc.119
已完成
不适用
A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration SystemLower Extremity Acute Limb IschemiaLE ALINCT04144959Penumbra Inc.119
已完成
不适用
Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in JapanAcute Limb IschemiaArterial Occlusion Mesenteric Artery SuperiorAcute DVT of Lower ExtremityNCT06446024Penumbra Inc.500