A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System
NCT04144959 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 119
Last updated 2025-06-27
Summary
The primary objective of this study is to collect safety and performance data on the Indigo Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).
Conditions
- Lower Extremity Acute Limb Ischemia
- LE ALI
Interventions
- DEVICE
-
Indigo Aspiration System
Indigo Aspiration System
Sponsors & Collaborators
-
Penumbra Inc.
lead INDUSTRY
Principal Investigators
-
Thomas Maldonado, MD · NYU Langone Medical Center
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-12-17
- Primary Completion
- 2023-01-02
- Completion
- 2023-10-20
- FDA Device
- Yes
Countries
- United States
- Germany
- Spain
Study Locations
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