A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System

Completed

Conditions studied: Lower Extremity Acute Limb Ischemia, LE ALI

In brief

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).

Key facts

Study ID

NCT04144959

Run by

Penumbra Inc.

People needed

119

Starts

2019-12-17

Expected to finish

2023-10-20

Last updated by the study team

2025-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient age ≥ 18
• Patient presents with acute (≤14 days) occlusion of lower limb artery(ies) (below inguinal ligament)
• Patient with a Rutherford Category I, IIa or IIb score
• Frontline treatment with Indigo Aspiration System
• Informed consent is obtained from either patient or legally authorized representative (LAR)

You may not qualify if…

• Life expectancy <1 year
• Vessel size <2 mm
• LE ALI secondary to dissections, vasculitis, and/or target vessel trauma
• Amputation in the ipsilateral limb
• Pregnancy or positive pregnancy test according to site specific standards of care (only required for women of child bearing potential, serum or urine acceptable)
• Absolute contraindication to contrast administration
• 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
• Currently participating in an investigational drug or device clinical trial that may confound the study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.

Where it is running

• Stanford University Medical Center — Stanford, California, United States
• Danbury Hospital — Danbury, Connecticut, United States
• Manatee Memorial Hospital — Bradenton, Florida, United States
• Baptist Hospital of Miami — Miami, Florida, United States
• University of Maryland — Baltimore, Maryland, United States
• Albany Medical Center — Albany, New York, United States
• Tisch Hospital NYU Langone Health — New York, New York, United States
• NC Heart and Vascular Research — Cary, North Carolina, United States
• Sanger Heart & Vascular Institute — Charlotte, North Carolina, United States
• Trihealth Good Samaritan Hospital of Cincinnati — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Holston Valley Medical — Kingsport, Tennessee, United States
• Baylor College of Medicine (St. Luke's Medical Center) — Houston, Texas, United States
• Sentara Vascular Specialists — Norfolk, Virginia, United States
• Klinikum rechts der Isar — München, Germany
• St. Franziskus-Hospital - Münster — Münster, Germany
• Hospital Clínico Universitario de Santiago — Santiago de Compostela, Spain

Full record on ClinicalTrials.gov

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