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

Sponsor
Penumbra Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03957473
Collaborator
(none)
400
Enrollment
25
Locations
21.4
Actual Duration (Months)
16
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Indigo Aspiration System

Study Design

Study Type:
Observational
Actual Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Aug 22, 2019
Actual Primary Completion Date :
Jan 18, 2021
Actual Study Completion Date :
Jun 2, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Final TIMI Flow Grade [Procedure]

  2. Final TIMI Thrombus Grade [Procedure]

  3. Myocardial Blush Grade [Procedure]

  4. Distal Embolization Rate [Procedure]

  5. Stent Thrombosis [180 Days]

  6. Stroke [30 Days]

  7. Major Bleeding [30 Days]

  8. All-Cause Mortality [180 Days]

  9. Cardiovascular Death [180 Days]

  10. Recurrent MI [180 Days]

  11. Cardiogenic Shock [180 Days]

  12. Class IV Heart Failure [180 Days]

  13. Incident of Device Related SAEs [180 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cedars Sinai Medical Center Los Angeles California United States 90048
2 St. Joseph Hospital - Orange Orange California United States 92868
3 UCSD Medical Center San Diego California United States 92103
4 Manatee Memorial Hospital Bradenton Florida United States 34208
5 Clearwater Cardiovascular Consultants Clearwater Florida United States 33756
6 Largo Medical Center Largo Florida United States 33770
7 AdventHealth Tampa (Florida Hospital Tampa) Tampa Florida United States 33613
8 Mercy Medical Des Moines Des Moines Iowa United States 50314
9 Jewish Hospital Louisville Kentucky United States 40202
10 St. John Hospital Detroit Michigan United States 48236
11 Metro Health Hospital Grand Rapids Michigan United States 49519
12 Metropolitan Heart & Vascular Coon Rapids Minnesota United States 55433
13 Washington University Saint Louis Missouri United States 63110
14 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
15 Desert Springs Hospital Las Vegas Nevada United States 89119
16 University at Buffalo Medical Center Buffalo New York United States 14260
17 NYU Langone New York New York United States 10016
18 NC Heart & Vascular Research Raleigh North Carolina United States 27607
19 Mercy West Hospital Cincinnati Ohio United States 45211
20 Lehigh Valley Hospital Allentown Pennsylvania United States 18103
21 Rapid City Regional Hospital Rapid City South Dakota United States 57701
22 Wellmont Holston Valley Medical Center Kingsport Tennessee United States 37660
23 Turkey Creek Medical Center Knoxville Tennessee United States 37934
24 Kingwood Medical Center Kingwood Texas United States 77339
25 Sentara Norfolk General Norfolk Virginia United States 23507

Sponsors and Collaborators

  • Penumbra Inc.

Investigators

  • Principal Investigator: S. Jay Mathews, MD, Manatee Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT03957473
Other Study ID Numbers:
  • CLP 15298
First Posted:
May 21, 2019
Last Update Posted:
Jun 25, 2021
Last Verified:
Jun 1, 2021
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
Additional relevant MeSH terms:
Thrombosis

Study Results

No Results Posted as of Jun 25, 2021