Study of the CAT RX Aspiration Catheter When Used in Patients With Large Occlusive Thrombus in Coronary Arteries
NCT03957473 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 400
Last updated 2023-10-10
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).
Conditions
- Coronary Vessel Occlusion
Interventions
- DEVICE
-
Indigo Aspiration System
Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
Sponsors & Collaborators
-
Penumbra Inc.
lead INDUSTRY
Principal Investigators
-
S. Jay Mathews, MD · Manatee Memorial Hospital
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-22
- Primary Completion
- 2021-01-18
- Completion
- 2021-06-02
Countries
- United States
Study Locations
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