Clinical trial NCT03957473: Study of the CAT RX Aspiration Catheter When Used in Patients With Large Occlusive Thrombus in Coronary Arteries
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Vessel Occlusion
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High thrombus burden patients presenting with acute coronary vessel occlusion who are referred for standard of care (SOC) PCI

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Composite of:
timeFrame: 30 days
Secondary outcomes:
measure: Final TIMI Flow Grade
timeFrame: Procedure
measure: Final TIMI Thrombus Grade
timeFrame: Procedure
measure: Myocardial Blush Grade
timeFrame: Procedure
measure: Distal Embolization Rate
timeFrame: Procedure
measure: Stent Thrombosis
timeFrame: 180 Days
measure: Stroke
timeFrame: 30 Days
measure: Major Bleeding
timeFrame: 30 Days
measure: All-Cause Mortality
timeFrame: 180 Days
measure: Cardiovascular Death
timeFrame: 180 Days
measure: Recurrent MI
timeFrame: 180 Days
measure: Cardiogenic Shock
timeFrame: 180 Days
measure: Class IV Heart Failure
timeFrame: 180 Days
measure: Incident of Device Related SAEs
timeFrame: 180 Days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Orange
country: United States
facility: St. Joseph Hospital - Orange
state: California
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: Bradenton
country: United States
facility: Manatee Memorial Hospital
state: Florida
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Largo
country: United States
facility: Largo Medical Center
state: Florida
city: Tampa
country: United States
facility: AdventHealth Tampa (Florida Hospital Tampa)
state: Florida
city: Des Moines
country: United States
facility: Mercy Medical Des Moines
state: Iowa
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Detroit
country: United States
facility: St. John Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Metro Health Hospital
state: Michigan
city: Coon Rapids
country: United States
facility: Metropolitan Heart & Vascular
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Las Vegas
country: United States
facility: Desert Springs Hospital
state: Nevada
city: Buffalo
country: United States
facility: University at Buffalo Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone
state: New York
city: Raleigh
country: United States
facility: NC Heart & Vascular Research
state: North Carolina
city: Cincinnati
country: United States
facility: Mercy West Hospital
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Kingsport
country: United States
facility: Wellmont Holston Valley Medical Center
state: Tennessee
city: Knoxville
country: United States
facility: Turkey Creek Medical Center
state: Tennessee
city: Kingwood
country: United States
facility: Kingwood Medical Center
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General
state: Virginia
Study officials:
affiliation: Manatee Memorial Hospital
name: S. Jay Mathews, MD
role: PRINCIPAL_INVESTIGATOR
References: