Study of the CAT RX Aspiration Catheter When Used in Patients With Large Occlusive Thrombus in Coronary Arteries

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Coronary Vessel Occlusion

Intervention / Treatment
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* Device: Indigo Aspiration System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single Arm<br>Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions | Device: Indigo Aspiration System<br>* Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of: | Cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association Class IV heart failure | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final TIMI Flow Grade | TIMI flow grading range 0-3, with higher grading representing better outcome | Procedure | 
| Final TIMI Thrombus Grade | TIMI Thrombus grading range 0-5, with lower grading representing better outcome | Procedure | 
| Myocardial Blush Grade | Myocardial blush grading range 0-3, with higher grading representing better outcome | Procedure | 
| Distal Embolization Rate |  | Procedure | 
| Stent Thrombosis |  | 180 Days | 
| Stroke |  | 30 Days | 
| Major Bleeding |  | 30 Days | 
| All-Cause Mortality |  | 180 Days | 
| Cardiovascular Death |  | 180 Days | 
| Recurrent MI |  | 180 Days | 
| Cardiogenic Shock |  | 180 Days | 
| Class IV Heart Failure |  | 180 Days | 
| Incident of Device Related SAEs |  | 180 Days |