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

NCT03957473 | Completed Results

• 1 other identifier: CLP 15298
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 25

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).

Conditions

Coronary Vessel Occlusion

Outcome Measures

Primary Outcomes (1)

• Composite of:

  Cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association Class IV heart failure

  30 days

Secondary Outcomes (13)

• Final TIMI Flow Grade

  Procedure

• Final TIMI Thrombus Grade

  Procedure

• Myocardial Blush Grade

  Procedure

• Distal Embolization Rate

  Procedure

• Stent Thrombosis

  180 Days

Study Arms (1)

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

Interventions

Indigo Aspiration System DEVICE

Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (25)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

St. Joseph Hospital - Orange

Orange, California, 92868, United States

Location

UCSD Medical Center

San Diego, California, 92103, United States

Location

Manatee Memorial Hospital

Bradenton, Florida, 34208, United States

Location

Clearwater Cardiovascular Consultants

Clearwater, Florida, 33756, United States

Location

Largo Medical Center

Largo, Florida, 33770, United States

Location

AdventHealth Tampa (Florida Hospital Tampa)

Tampa, Florida, 33613, United States

Location

Mercy Medical Des Moines

Des Moines, Iowa, 50314, United States

Location

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

St. John Hospital

Detroit, Michigan, 48236, United States

Location

Metro Health Hospital

Grand Rapids, Michigan, 49519, United States

Location

Metropolitan Heart & Vascular

Coon Rapids, Minnesota, 55433, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Desert Springs Hospital

Las Vegas, Nevada, 89119, United States

Location

University at Buffalo Medical Center

Buffalo, New York, 14260, United States

Location

NYU Langone

New York, New York, 10016, United States

Location

NC Heart & Vascular Research

Raleigh, North Carolina, 27607, United States

Location

Mercy West Hospital

Cincinnati, Ohio, 45211, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, 37660, United States

Location

Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

Location

Kingwood Medical Center

Kingwood, Texas, 77339, United States

Location

Sentara Norfolk General

Norfolk, Virginia, 23507, United States

Location

Results Point of Contact

• Title: Study Manager
• Organization: Penumbra, Inc.

apascua@penumbrainc.com

+1 415-601-9561

Study Officials

• S. Jay Mathews, MD

  Manatee Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: August 22, 2019
• Primary Completion: January 18, 2021
• Study Completion: June 2, 2021
• Last Updated: October 10, 2023
• Results First Posted: October 10, 2023

Record last verified: 2023-01

Locations

US (25)