Recruiting

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

Sponsor:

Penumbra Inc.

Code:

NCT06747117

Conditions

Lower Extremity Acute Limb Ischemia

LE ALI

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Indigo Aspiration System

Study Details

Brief 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).

Conditions

Lower Extremity Acute Limb Ischemia

LE ALI

Study ID

NCT06747117

Start date

May 18, 2025

Status verified date

Aug, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with lower extremity acute limb ischemia

Device: Indigo Aspiration System

Interventions

Indigo Aspiration System

Mechanical aspiration thrombectomy with the Indigo Aspiration System.

Primary outcome measure

Target Limb Salvage Rate [ Time Frame: 30 Days Post-Procedure ]

Central Contacts and Locations

Central contacts

Marina Mello

+14078108634 mmello@penumbrainc.com

Jemymah Allen

+13109485738 jallen@penumbrainc.com

Locations

HonorHealth Scottsdale Osborn Medical Center

Recruiting

Scottsdale, Arizona, United States, 85251

Sharp Memorial Hospital

Recruiting

San Diego, California, United States, 92123

Community Memorial Hospital

Recruiting

Ventura, California, United States, 93003

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06520

Christiana Care Health Services, Inc.

Recruiting

Newark, Delaware, United States, 19713

Manatee Memorial Hospital

Recruiting

Bradenton, Florida, United States, 34208

University of Florida Shands Hospital

Recruiting

Gainesville, Florida, United States, 32608

Radiology and Imaging Specialists

Recruiting

Lakeland, Florida, United States, 33805

Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

Recruiting

Miami, Florida, United States, 33176

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Indiana University Health Methodist Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Community Hospital

Recruiting

Munster, Indiana, United States, 46321

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

UMass Memorial Medical Center

Recruiting

Worcester, Massachusetts, United States, 01655

Saint Louis University Hospital

Recruiting

St Louis, Missouri, United States, 63104

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03766

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

UNC Medical Center Hospital

Recruiting

Chapel Hill, North Carolina, United States, 27514

Sanger Heart & Vascular Institute

Recruiting

Concord, North Carolina, United States, 28204

NC Heart and Vascular Research, LLC

Recruiting

Raleigh, North Carolina, United States, 27607

TriHealth Good Samaritan Hospital

Recruiting

Cincinnati, Ohio, United States, 45220

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Prisma Health Greenville Memorial Hospital

Recruiting

Greenville, South Carolina, United States, 29605

Lexington Medical Center

Recruiting

West Columbia, South Carolina, United States, 29169

Jackson-Madison County General Hospital

Recruiting

Jackson, Tennessee, United States, 38301

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

William P. Clements Jr. University Hospital

Recruiting

Dallas, Texas, United States, 75235

Baylor St. Luke's Medical Center

Recruiting

Houston, Texas, United States, 77030

Baylor Scott & White The Heart Hospital - Plano

Recruiting

Plano, Texas, United States, 75093

The Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Penumbra Inc.

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Penumbra Inc. on 2026-08-31.