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).

Study Overview

• Status: Completed
• Conditions: Coronary Vessel Occlusion
• Intervention / Treatment: Device: Indigo Aspiration System

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • Orange, California, United States, 92868
      • St. Joseph Hospital - Orange
    • San Diego, California, United States, 92103
      • UCSD Medical Center
  • Florida
    • Bradenton, Florida, United States, 34208
      • Manatee Memorial Hospital
    • Clearwater, Florida, United States, 33756
      • Clearwater Cardiovascular Consultants
    • Largo, Florida, United States, 33770
      • Largo Medical Center
    • Tampa, Florida, United States, 33613
      • AdventHealth Tampa (Florida Hospital Tampa)
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Mercy Medical Des Moines
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Jewish Hospital
  • Michigan
    • Detroit, Michigan, United States, 48236
      • St. John Hospital
    • Grand Rapids, Michigan, United States, 49519
      • Metro Health Hospital
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Metropolitan Heart & Vascular
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
    • Saint Louis, Missouri, United States, 63131
      • Missouri Baptist Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Desert Springs Hospital
  • New York
    • Buffalo, New York, United States, 14260
      • University at Buffalo Medical Center
    • New York, New York, United States, 10016
      • NYU Langone
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • NC Heart & Vascular Research
  • Ohio
    • Cincinnati, Ohio, United States, 45211
      • Mercy West Hospital
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Rapid City Regional Hospital
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Holston Valley Medical Center
    • Knoxville, Tennessee, United States, 37934
      • Turkey Creek Medical Center
  • Texas
    • Kingwood, Texas, United States, 77339
      • Kingwood Medical Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single Arm; 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; Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4

What is the study measuring?

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
Stroke		30 Days
Distal Embolization Rate		Procedure
Stent Thrombosis		180 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
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

Collaborators and Investigators

• Sponsor: Penumbra Inc.
• Investigators: Principal Investigator: S. Jay Mathews, MD, Manatee Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2019
• Primary Completion (Actual): January 18, 2021
• Study Completion (Actual): June 2, 2021

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: CLP 15298

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No