New device aims to save legs from clot emergencies

NCT ID NCT06747117

Recruiting now Disease control Sponsor: Penumbra Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study is testing a device called the Indigo Aspiration System to remove blood clots from leg arteries in people with acute limb ischemia, a condition where a clot suddenly blocks blood flow. About 300 participants will undergo a procedure where the device sucks out the clot. The main goal is to see if the device can save the limb and restore blood flow safely.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Indigo Aspiration System (device for mechanical clot removal)
What this could lead to: If successful, this could provide a safe and effective way to quickly restore blood flow in leg arteries, potentially saving limbs from amputation.
What could go wrong: This is an early-stage study (no phase specified) with 300 participants, so results may not apply to all patients. Risks include bleeding, vessel damage, or the device failing to remove the clot.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome limb ischemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

LE ALI LOWER EXTREMITY ACUTE LIMB ISCHEMIA

Contacts and locations

Locations

ASST Degli Spedali Civili di Brescia
RECRUITING

Brescia, 25123, Italy
Baptist Hospital of Miami, Miami Cardiac and Vascular Institute
RECRUITING

Miami, Florida, 33176, United States
Baylor Scott & White The Heart Hospital - Plano
RECRUITING

Plano, Texas, 75093, United States
Baylor St. Luke's Medical Center
RECRUITING

Houston, Texas, 77030, United States
Christiana Care Health Services, Inc.
RECRUITING

Newark, Delaware, 19713, United States
Cleveland Clinic
RECRUITING

Cleveland, Ohio, 44195, United States
Community Hospital
RECRUITING

Munster, Indiana, 46321, United States
Community Memorial Hospital
RECRUITING

Ventura, California, 93003, United States
Dartmouth Hitchcock Medical Center
RECRUITING

Lebanon, New Hampshire, 03766, United States
Emory University Hospital
RECRUITING

Atlanta, Georgia, 30322, United States
Flinders Medical Centre
RECRUITING

Bedford Park, South Australia, 5042, Australia
HonorHealth Scottsdale Osborn Medical Center
RECRUITING

Scottsdale, Arizona, 85251, United States
Jackson-Madison County General Hospital
RECRUITING

Jackson, Tennessee, 38301, United States
Klinikum Stuttgart - Katharinenhospital
RECRUITING

Stuttgart, 70174, Germany
Lausanne University Hospital
RECRUITING

Lausanne, 1005, Switzerland
Lexington Medical Center
RECRUITING

West Columbia, South Carolina, 29169, United States
Manatee Memorial Hospital
RECRUITING

Bradenton, Florida, 34208, United States
Mount Sinai Hospital
RECRUITING

New York, New York, 10029, United States
NC Heart and Vascular Research, LLC
RECRUITING

Raleigh, North Carolina, 27607, United States
NYU Langone Health
RECRUITING

New York, New York, 10016, United States
OSF Saint Francis Medical Center
WITHDRAWN

Peoria, Illinois, 61637, United States
Ospedale Policlinico San Martino, Genova
RECRUITING

Genoa, Italy
Prisma Health Greenville Memorial Hospital
RECRUITING

Greenville, South Carolina, 29605, United States
Radiology and Imaging Specialists
RECRUITING

Lakeland, Florida, 33805, United States
Royal North Shore Hospital
RECRUITING

Sydney, NSW 2065, Australia
Saint Louis University Hospital
RECRUITING

St Louis, Missouri, 63104, United States
Sanger Heart & Vascular Institute
RECRUITING

Concord, North Carolina, 28204, United States
Sharp Memorial Hospital
RECRUITING

San Diego, California, 92123, United States
Tampa General Hospital
RECRUITING

Tampa, Florida, 33606, United States
The Medical College of Wisconsin
RECRUITING

Milwaukee, Wisconsin, 53226, United States
TriHealth Good Samaritan Hospital
RECRUITING

Cincinnati, Ohio, 45220, United States
UFMG Hospital Risoleta Tolentino Neves
RECRUITING

Belo Horizonte, 31744-012, Brazil
UMass Memorial Medical Center
RECRUITING

Worcester, Massachusetts, 01655, United States
UNC Medical Center Hospital
RECRUITING

Chapel Hill, North Carolina, 27514, United States
University of Colorado Hospital
RECRUITING

Aurora, Colorado, 80045, United States
University of Florida Shands Hospital
RECRUITING

Gainesville, Florida, 32608, United States
University of Kentucky
RECRUITING

Lexington, Kentucky, 40536, United States
University of Maryland
RECRUITING

Baltimore, Maryland, 21201, United States
Universitätsklinik Leipzig
RECRUITING

Leipzig, 04103, Germany
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37232, United States
William P. Clements Jr. University Hospital
RECRUITING

Dallas, Texas, 75235, United States
Yale New Haven Hospital
RECRUITING

New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.

New device for leg clots tested in first human survey