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

January 4, 2023 updated by: Penumbra Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite of:
Time Frame: 30 days
Cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association Class IV heart failure
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stroke
Time Frame: 30 Days
30 Days
Distal Embolization Rate
Time Frame: Procedure
Procedure
Stent Thrombosis
Time Frame: 180 Days
180 Days
Major Bleeding
Time Frame: 30 Days
30 Days
All-Cause Mortality
Time Frame: 180 Days
180 Days
Cardiovascular Death
Time Frame: 180 Days
180 Days
Recurrent MI
Time Frame: 180 Days
180 Days
Cardiogenic Shock
Time Frame: 180 Days
180 Days
Class IV Heart Failure
Time Frame: 180 Days
180 Days
Incident of Device Related SAEs
Time Frame: 180 Days
180 Days
Final TIMI Flow Grade
Time Frame: Procedure
TIMI flow grading range 0-3, with higher grading representing better outcome
Procedure
Final TIMI Thrombus Grade
Time Frame: Procedure
TIMI Thrombus grading range 0-5, with lower grading representing better outcome
Procedure
Myocardial Blush Grade
Time Frame: Procedure
Myocardial blush grading range 0-3, with higher grading representing better outcome
Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penumbra Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: S. Jay Mathews, MD, Manatee Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 22, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 18, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 2, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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