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

Study results available
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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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04144959 on ClinicalTrials.gov