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OpenTrials
Completed

NCT Number: NCT03957473

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars Sinai Medical Center, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indigo Aspiration System

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Final TIMI Flow Grade

    Time frame: Procedure

    TIMI flow grading range 0-3, with higher grading representing better outcome

  2. Final TIMI Thrombus Grade

    Time frame: Procedure

    TIMI Thrombus grading range 0-5, with lower grading representing better outcome

  3. Myocardial Blush Grade

    Time frame: Procedure

    Myocardial blush grading range 0-3, with higher grading representing better outcome

  4. Distal Embolization Rate

    Time frame: Procedure

  5. Stent Thrombosis

    Time frame: 180 Days

  6. Stroke

    Time frame: 30 Days

  7. Major Bleeding

    Time frame: 30 Days

  8. All-Cause Mortality

    Time frame: 180 Days

  9. Cardiovascular Death

    Time frame: 180 Days

  10. Recurrent MI

    Time frame: 180 Days

  11. Cardiogenic Shock

    Time frame: 180 Days

  12. Class IV Heart Failure

    Time frame: 180 Days

  13. Incident of Device Related SAEs

    Time frame: 180 Days

Sponsors and collaborators

Lead sponsor

Penumbra Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 21, 2019
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.