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

Completed

• Conditions: Coronary Vessel Occlusion
• Interventions: Device: Indigo Aspiration System

• Registration Number: NCT03957473
• Lead Sponsor: Penumbra Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-21
• Study Start: 2019-08-22
• Primary Completion: 2021-01-18
• Study Completion: 2021-06-02
• Results First Submitted: 2022-03-23
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-04
• Last Update Submitted: 2023-01-04
• Results First Posted: 2023-10-10
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single Arm	Indigo Aspiration System	Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions

Primary Outcome Measures

Name	Time	Method
Composite of:	30 days	Cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association Class IV heart failure

Secondary Outcome Measures

Name	Time	Method
All-Cause Mortality	180 Days
Stroke	30 Days
Final TIMI Thrombus Grade	Procedure	TIMI Thrombus grading range 0-5, with lower grading representing better outcome
Cardiogenic Shock	180 Days
Final TIMI Flow Grade	Procedure	TIMI flow grading range 0-3, with higher grading representing better outcome
Major Bleeding	30 Days
Recurrent MI	180 Days
Myocardial Blush Grade	Procedure	Myocardial blush grading range 0-3, with higher grading representing better outcome
Class IV Heart Failure	180 Days
Incident of Device Related SAEs	180 Days
Distal Embolization Rate	Procedure
Stent Thrombosis	180 Days
Cardiovascular Death	180 Days

Trial Locations

Locations (25)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Mercy West Hospital; 🇺🇸 Cincinnati, Ohio, United States

Desert Springs Hospital; 🇺🇸 Las Vegas, Nevada, United States

UCSD Medical Center; 🇺🇸 San Diego, California, United States

St. Joseph Hospital - Orange; 🇺🇸 Orange, California, United States

Manatee Memorial Hospital; 🇺🇸 Bradenton, Florida, United States

Clearwater Cardiovascular Consultants; 🇺🇸 Clearwater, Florida, United States

AdventHealth Tampa (Florida Hospital Tampa); 🇺🇸 Tampa, Florida, United States

Largo Medical Center; 🇺🇸 Largo, Florida, United States

Jewish Hospital; 🇺🇸 Louisville, Kentucky, United States

Metropolitan Heart & Vascular; 🇺🇸 Coon Rapids, Minnesota, United States

St. John Hospital; 🇺🇸 Detroit, Michigan, United States

Metro Health Hospital; 🇺🇸 Grand Rapids, Michigan, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Missouri Baptist Medical Center; 🇺🇸 Saint Louis, Missouri, United States

University at Buffalo Medical Center; 🇺🇸 Buffalo, New York, United States

NYU Langone; 🇺🇸 New York, New York, United States

Lehigh Valley Hospital; 🇺🇸 Allentown, Pennsylvania, United States

NC Heart & Vascular Research; 🇺🇸 Raleigh, North Carolina, United States

Rapid City Regional Hospital; 🇺🇸 Rapid City, South Dakota, United States

Wellmont Holston Valley Medical Center; 🇺🇸 Kingsport, Tennessee, United States

Kingwood Medical Center; 🇺🇸 Kingwood, Texas, United States

Sentara Norfolk General; 🇺🇸 Norfolk, Virginia, United States

Turkey Creek Medical Center; 🇺🇸 Knoxville, Tennessee, United States

Mercy Medical Des Moines; 🇺🇸 Des Moines, Iowa, United States