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

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

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).

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