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

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ClinicalTrials.gov Identifier: NCT03957473
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Coronary Vessel Occlusion Device: Indigo Aspiration System

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Study Type : Observational
Estimated 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 : August 22, 2019
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Group/Cohort 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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Final TIMI Flow Grade [ Time Frame: Procedure ]
  2. Final TIMI Thrombus Grade [ Time Frame: Procedure ]
  3. Myocardial Blush Grade [ Time Frame: Procedure ]
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957473


Contacts
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Contact: Erin Archard 510-995-9801 earchard@penumbrainc.com
Contact: Michaella Corso 510-995-2079 mcorso@penumbrainc.com

Locations
Show Show 25 study locations
Sponsors and Collaborators
Penumbra Inc.
Investigators
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Principal Investigator: S. Jay Mathews, MD Manatee Memorial Hospital
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Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT03957473    
Other Study ID Numbers: CLP 15298
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases