Study of the CAT RX Aspiration Catheter When Used in Patients With Large Occlusive Thrombus in Co… (NCT03957473) | Clinical Trial Compass
CompletedNot Applicable
Study of the CAT RX Aspiration Catheter When Used in Patients With Large Occlusive Thrombus in Coronary Arteries
United States400 participantsStarted 2019-08-22
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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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