Coronary Vessel OcclusionNCT03957473
Study of the CAT RX Aspiration Catheter When Used in Patients With Large Occlusive Thrombus in Coronary Arteries
An observational study of Coronary Vessel Occlusion, run by Penumbra Inc. at 25 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Vessel Occlusion
- What is being tested?
- Indigo Aspiration System
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 25 sitesUnited States
- Study dates
- 22 Aug 2019to 2 Jun 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: High thrombus burden patients presenting with acute coronary vessel occlusion who are referred for standard of care (SOC) PCI
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Manatee Memorial Hospital
Bradenton, Florida, 34208
University at Buffalo Medical Center
Buffalo, New York, 14260
Mercy West Hospital
Cincinnati, Ohio, 45211
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756
Metropolitan Heart & Vascular
Coon Rapids, Minnesota, 55433
Mercy Medical Des Moines
Des Moines, Iowa, 50314
St. John Hospital
Detroit, Michigan, 48236
Metro Health Hospital
Grand Rapids, Michigan, 49519
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660
Kingwood Medical Center
Kingwood, Texas, 77339
Turkey Creek Medical Center
Knoxville, Tennessee, 37934
Largo Medical Center
Largo, Florida, 33770
Desert Springs Hospital
Las Vegas, Nevada, 89119
Cedars Sinai Medical Center
Los Angeles, California, 90048
Jewish Hospital
Louisville, Kentucky, 40202
NYU Langone
New York, New York, 10016
Sentara Norfolk General
Norfolk, Virginia, 23507
St. Joseph Hospital - Orange
Orange, California, 92868
NC Heart & Vascular Research
Raleigh, North Carolina, 27607
Rapid City Regional Hospital
Rapid City, South Dakota, 57701
UCSD Medical Center
San Diego, California, 92103
Washington University
St Louis, Missouri, 63110
Missouri Baptist Medical Center
St Louis, Missouri, 63131
AdventHealth Tampa (Florida Hospital Tampa)
Tampa, Florida, 33613
About this study
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
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).
- Conditions
- Coronary Vessel Occlusion
- Being tested
- Indigo Aspiration System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indigo Aspiration SystemDevice
Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions Receives: Device: Indigo Aspiration System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of:
Cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association Class IV heart failure
Measured: 30 days
Secondary outcomes (13)
Final TIMI Flow Grade
TIMI flow grading range 0-3, with higher grading representing better outcome
Measured: Procedure
Final TIMI Thrombus Grade
TIMI Thrombus grading range 0-5, with lower grading representing better outcome
Measured: Procedure
Myocardial Blush Grade
Myocardial blush grading range 0-3, with higher grading representing better outcome
Measured: Procedure
Distal Embolization Rate
Measured: Procedure
Stent Thrombosis
Measured: 180 Days
Stroke
Measured: 30 Days
Major Bleeding
Measured: 30 Days
All-Cause Mortality
Measured: 180 Days
Cardiovascular Death
Measured: 180 Days
Recurrent MI
Measured: 180 Days
Cardiogenic Shock
Measured: 180 Days
Class IV Heart Failure
Measured: 180 Days
Incident of Device Related SAEs
Measured: 180 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start22 Aug 2019
- Primary completion18 Jan 2021
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Vessel OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- S. Jay Mathews, MD, Principal investigator, Manatee Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957473
- Sponsor's protocol ID
- CLP 15298
- Status last verified
- Jan 2023
- First submitted
- 17 May 2019
- Last updated
- 10 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03957473
- Acronym / sponsor ID
- CLP 15298
- Conditions
- Coronary Vessel Occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Posted 10 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | – | Device: Indigo Aspiration SystemSingle Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High thrombus burden patients presenting with acute coronary vessel occlusion who are referred for standard of care (SOC) PCI
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indigo Aspiration SystemIndigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4 | Device | Single Arm |
Primary outcome
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
13 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S. Jay Mathews, MD principal investigator
Manatee Memorial Hospital
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Vessel Occlusion, run by Penumbra Inc. at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of: (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.