N/A
Completed N=400
Study of the CAT RX Aspiration Catheter When Used in Patients With Large Occlusive Thrombus in Coronary Arteries
Coronary Vessel Occlusion
Source: ClinicalTrials.gov NCT03957473 ↗
Enrolled (actual)
400
Serious AEs
36.0%
Results posted
Oct 2023
Primary outcomePrimary: Composite of: — 14 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite of: |
14 | — |
| SECONDARY Final TIMI Flow Grade |
0; 0; 10; 390 | — |
| SECONDARY Final TIMI Thrombus Grade |
398; 1; 1; 0; 0; 0 | — |
| SECONDARY Myocardial Blush Grade |
0; 0; 1; 399 | — |
| SECONDARY Distal Embolization Rate |
3 | — |
| SECONDARY Stent Thrombosis |
9 | — |
| SECONDARY Stroke |
3 | — |
| SECONDARY Major Bleeding |
4 | — |
| SECONDARY All-Cause Mortality |
9 | — |
| SECONDARY Cardiovascular Death |
4 | — |
| SECONDARY Recurrent MI |
10 | — |
| SECONDARY Cardiogenic Shock |
8 | — |
| SECONDARY Class IV Heart Failure |
4 | — |
| SECONDARY Incident of Device Related SAEs |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03957473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.