Coronary Vessel Occlusion Clinical Trial
Official title:
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
| NCT number | NCT03957473 |
| Other study ID # | CLP 15298 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 22, 2019 |
| Est. completion date | June 2, 2021 |
| Verified date | January 2023 |
| Source | Penumbra Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 400 |
| Est. completion date | June 2, 2021 |
| Est. primary completion date | January 18, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
| United States | Manatee Memorial Hospital | Bradenton | Florida |
| United States | University at Buffalo Medical Center | Buffalo | New York |
| United States | Mercy West Hospital | Cincinnati | Ohio |
| United States | Clearwater Cardiovascular Consultants | Clearwater | Florida |
| United States | Metropolitan Heart & Vascular | Coon Rapids | Minnesota |
| United States | Mercy Medical Des Moines | Des Moines | Iowa |
| United States | St. John Hospital | Detroit | Michigan |
| United States | Metro Health Hospital | Grand Rapids | Michigan |
| United States | Wellmont Holston Valley Medical Center | Kingsport | Tennessee |
| United States | Kingwood Medical Center | Kingwood | Texas |
| United States | Turkey Creek Medical Center | Knoxville | Tennessee |
| United States | Largo Medical Center | Largo | Florida |
| United States | Desert Springs Hospital | Las Vegas | Nevada |
| United States | Cedars Sinai Medical Center | Los Angeles | California |
| United States | Jewish Hospital | Louisville | Kentucky |
| United States | NYU Langone | New York | New York |
| United States | Sentara Norfolk General | Norfolk | Virginia |
| United States | St. Joseph Hospital - Orange | Orange | California |
| United States | NC Heart & Vascular Research | Raleigh | North Carolina |
| United States | Rapid City Regional Hospital | Rapid City | South Dakota |
| United States | Missouri Baptist Medical Center | Saint Louis | Missouri |
| United States | Washington University | Saint Louis | Missouri |
| United States | UCSD Medical Center | San Diego | California |
| United States | AdventHealth Tampa (Florida Hospital Tampa) | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Penumbra Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Composite of: | Cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association Class IV heart failure | 30 days | |
| Secondary | Final TIMI Flow Grade | TIMI flow grading range 0-3, with higher grading representing better outcome | Procedure | |
| Secondary | Final TIMI Thrombus Grade | TIMI Thrombus grading range 0-5, with lower grading representing better outcome | Procedure | |
| Secondary | Myocardial Blush Grade | Myocardial blush grading range 0-3, with higher grading representing better outcome | Procedure | |
| Secondary | Distal Embolization Rate | Procedure | ||
| Secondary | Stent Thrombosis | 180 Days | ||
| Secondary | Stroke | 30 Days | ||
| Secondary | Major Bleeding | 30 Days | ||
| Secondary | All-Cause Mortality | 180 Days | ||
| Secondary | Cardiovascular Death | 180 Days | ||
| Secondary | Recurrent MI | 180 Days | ||
| Secondary | Cardiogenic Shock | 180 Days | ||
| Secondary | Class IV Heart Failure | 180 Days | ||
| Secondary | Incident of Device Related SAEs | 180 Days |