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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03957473
Enrollment
400
Registered
2019-05-21
Start date
2019-08-22
Completion date
2021-06-02
Last updated
2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Vessel Occlusion

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).

Interventions

DEVICEIndigo Aspiration System

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

Sponsors

Penumbra Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Composite of:30 daysCardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association Class IV heart failure

Secondary

MeasureTime frameDescription
Final TIMI Thrombus GradeProcedureTIMI Thrombus grading range 0-5, with lower grading representing better outcome
Myocardial Blush GradeProcedureMyocardial blush grading range 0-3, with higher grading representing better outcome
Distal Embolization RateProcedure—
Stent Thrombosis180 Days—
Stroke30 Days—
Major Bleeding30 Days—
Final TIMI Flow GradeProcedureTIMI flow grading range 0-3, with higher grading representing better outcome
Cardiovascular Death180 Days—
Recurrent MI180 Days—
Cardiogenic Shock180 Days—
Class IV Heart Failure180 Days—
Incident of Device Related SAEs180 Days—
All-Cause Mortality180 Days—

Countries

United States

Participant flow

Participants by arm

ArmCount
Single Arm
Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
400
Total400

Baseline characteristics

CharacteristicSingle Arm
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
145 Participants
Age, Categorical
Between 18 and 65 years
255 Participants
Age, Continuous60.4 years
STANDARD_DEVIATION 12.21
Ethnicity (NIH/OMB)
Hispanic or Latino
14 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
378 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
8 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
Race (NIH/OMB)
Asian
12 Participants
Race (NIH/OMB)
Black or African American
31 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
3 Participants
Race (NIH/OMB)
Unknown or Not Reported
10 Participants
Race (NIH/OMB)
White
341 Participants
Region of Enrollment
United States
400 participants
Sex: Female, Male
Female
95 Participants
Sex: Female, Male
Male
305 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
10 / 400
other
Total, other adverse events
30 / 400
serious
Total, serious adverse events
144 / 400

Outcome results

Primary

Composite of:

Cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association Class IV heart failure

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Single ArmComposite of:14 Participants
Secondary

All-Cause Mortality

Time frame: 180 Days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Single ArmAll-Cause Mortality9 Participants
Secondary

Cardiogenic Shock

Time frame: 180 Days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Single ArmCardiogenic Shock8 Participants
Secondary

Cardiovascular Death

Time frame: 180 Days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Single ArmCardiovascular Death4 Participants
Secondary

Class IV Heart Failure

Time frame: 180 Days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Single ArmClass IV Heart Failure4 Participants
Secondary

Distal Embolization Rate

Time frame: Procedure

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Single ArmDistal Embolization Rate3 Participants
Secondary

Final TIMI Flow Grade

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

Time frame: Procedure

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Single ArmFinal TIMI Flow GradeTIMI 00 Participants
Single ArmFinal TIMI Flow GradeTIMI 10 Participants
Single ArmFinal TIMI Flow GradeTIMI 210 Participants
Single ArmFinal TIMI Flow GradeTIMI 3390 Participants
Secondary

Final TIMI Thrombus Grade

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

Time frame: Procedure

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Single ArmFinal TIMI Thrombus GradeGrade 0398 Participants
Single ArmFinal TIMI Thrombus GradeGrade 11 Participants
Single ArmFinal TIMI Thrombus GradeGrade 21 Participants
Single ArmFinal TIMI Thrombus GradeGrade 30 Participants
Single ArmFinal TIMI Thrombus GradeGrade 40 Participants
Single ArmFinal TIMI Thrombus GradeGrade 50 Participants
Secondary

Incident of Device Related SAEs

Time frame: 180 Days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Single ArmIncident of Device Related SAEs0 Participants
Secondary

Major Bleeding

Time frame: 30 Days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Single ArmMajor Bleeding4 Participants
Secondary

Myocardial Blush Grade

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

Time frame: Procedure

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Single ArmMyocardial Blush GradeGrade 21 Participants
Single ArmMyocardial Blush GradeGrade 3399 Participants
Single ArmMyocardial Blush GradeGrade 00 Participants
Single ArmMyocardial Blush GradeGrade 10 Participants
Secondary

Recurrent MI

Time frame: 180 Days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Single ArmRecurrent MI10 Participants
Secondary

Stent Thrombosis

Time frame: 180 Days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Single ArmStent Thrombosis9 Participants
Secondary

Stroke

Time frame: 30 Days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Single ArmStroke3 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026