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NCT06747117Recruiting

A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)

Penumbra Inc.

Start Date

5/18/2025

Completion Date

1/1/2029

Summary

The primary objective of this study is to collect and evaluate clinical evidence supporting the safety and performance of the Indigo™ Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Age ≥18 years * Patients with a confirmed diagnosis of lower limb arterial occlusion located in the common iliac or below, with a minimum of 2 cm of proximal patency in the common iliac * Acute occlusion with symptom duration of 14 days or less at presentation * ALI Rutherford Category I, IIa or IIb * First-line treatment with the Indigo Aspiration System using Computer Assisted Vacuum Thrombectomy (CAVT) aspiration tubing * Informed consent is obtained from either patient or legally authorized representative (LAR) per Institutional Review Board/Ethics Committee requirements * Previously enrolled patients presenting with a new acute occlusion in the contralateral limb meeting all eligibility criteria may be re-enrolled if the new acute occlusion is greater than 30 days from the initial index procedure Exclusion Criteria: * Life expectancy \<1 year * Target vessel size \<2 mm * Target thrombus is in the aorta or isolated profunda artery * Prior major amputation (proximal to the tarsometatarsal joint) in the target limb * Prior minor amputation in the target limb within the past 6 months that is not completely healed or cannot bear weight * LE ALI secondary to dissection, vasculitis, or target vessel trauma, including iatrogenic etiology from treatment of a proximal location in the target limb, and non-thrombotic material such as tumor fragments, fat emboli, septic emboli, and foreign bodies * Target thrombus in a vein bypass graft, previously revised bypass grafts, bypass grafts placed \< 3 months prior to index ALI symptom onset, or bypass grafts with a distal anastomosis below the popliteal artery * Treatment of the index event with thrombolytics or any other endovascular or open surgical method prior to enrollment * Pregnancy * Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated * Other medical, behavioral, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study * Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become

Interventions

DEVICE

Indigo Aspiration System

Interested in This Trial?

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Conditions

Lower Extremity Acute Limb IschemiaLE ALI

Locations

HonorHealth Scottsdale Osborn Medical Center

Scottsdale, Arizona 85251

United States

Sharp Memorial Hospital

San Diego, California 92123

United States

Community Memorial Hospital

Ventura, California 93003

United States

University of Colorado Hospital

Aurora, Colorado 80045

United States

Yale New Haven Hospital

New Haven, Connecticut 06520

United States

Christiana Care Health Services, Inc.

Newark, Delaware 19713

United States

Manatee Memorial Hospital

Bradenton, Florida 34208

United States

University of Florida Shands Hospital

Gainesville, Florida 32608

United States

Radiology and Imaging Specialists

Lakeland, Florida 33805

United States

Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

Miami, Florida 33176

United States

Tampa General Hospital

Tampa, Florida 33606

United States

Emory University Hospital

Atlanta, Georgia 30322

United States

OSF Saint Francis Medical Center

Peoria, Illinois 61637

United States

Community Hospital

Munster, Indiana 46321

United States

University of Kentucky

Lexington, Kentucky 40536

United States

University of Maryland

Baltimore, Maryland 21201

United States

UMass Memorial Medical Center

Worcester, Massachusetts 01655

United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire 03766

United States

NYU Langone Health

New York, New York 10016

United States

Mount Sinai Hospital

New York, New York 10029

United States

UNC Medical Center Hospital

Chapel Hill, North Carolina 27514

United States

Sanger Heart & Vascular Institute

Concord, North Carolina 28204

United States

NC Heart and Vascular Research, LLC

Raleigh, North Carolina 27607

United States

TriHealth Good Samaritan Hospital

Cincinnati, Ohio 45220

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina 29605

United States

Lexington Medical Center

West Columbia, South Carolina 29169

United States

Jackson-Madison County General Hospital

Jackson, Tennessee 38301

United States

William P. Clements Jr. University Hospital

Dallas, Texas 75235

United States

Baylor St. Luke's Medical Center

Houston, Texas 77030

United States

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas 75093

United States

The Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Flinders Medical Centre

Bedford Park, South Australia 5042

Australia

Universitätsklinik Leipzig

Leipzig, 04103

Germany

Klinikum Stuttgart - Katharinenhospital

Stuttgart, 70174

Germany

ASST Degli Spedali Civili di Brescia

Brescia, 25123

Italy

Ospedale Policlinico San Martino, Genova

Genoa,

Italy

Lausanne University Hospital

Lausanne, 1005

Switzerland