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 |
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Recruitment Status :
Recruiting
First Posted : May 21, 2019
Last Update Posted : August 24, 2020
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Sponsor:
Penumbra Inc.
Information provided by (Responsible Party):
Penumbra Inc.
- Study Details
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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 |
| 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 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Single Arm
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions
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Device: Indigo Aspiration System
Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4 |
Primary Outcome Measures :
- 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 :
- Final TIMI Flow Grade [ Time Frame: Procedure ]
- Final TIMI Thrombus Grade [ Time Frame: Procedure ]
- Myocardial Blush Grade [ Time Frame: Procedure ]
- Distal Embolization Rate [ Time Frame: Procedure ]
- Stent Thrombosis [ Time Frame: 180 Days ]
- Stroke [ Time Frame: 30 Days ]
- Major Bleeding [ Time Frame: 30 Days ]
- All-Cause Mortality [ Time Frame: 180 Days ]
- Cardiovascular Death [ Time Frame: 180 Days ]
- Recurrent MI [ Time Frame: 180 Days ]
- Cardiogenic Shock [ Time Frame: 180 Days ]
- Class IV Heart Failure [ Time Frame: 180 Days ]
- 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
| Contact: Erin Archard | 510-995-9801 | earchard@penumbrainc.com | |
| Contact: Michaella Corso | 510-995-2079 | mcorso@penumbrainc.com |
Locations
Show 25 study locations
Sponsors and Collaborators
Penumbra Inc.
Investigators
| Principal Investigator: | S. Jay Mathews, MD | Manatee Memorial Hospital |
| 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 |
| 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 |