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

NCT06747117 | Recruiting FDA Device

• 1 other identifier: CLP 30000
• Study Type: observational
• Target: 300
• Locations: 5 countries
• Sites: 33

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

LE ALI; Lower Extremity Acute Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• Target Limb Salvage Rate

  30 Days Post-Procedure

Secondary Outcomes (6)

• Technical Success

  Immediate Post Procedure

• Primary Patency at 30 Days

  30 Days Post-Procedure

• Rates of Device-related Major Bleeding

  Procedure, 30 Days, and 180 Days Post-Procedure

• Rates of Device-related Distal Embolization

  During Procedure

• Rates of Device-related Serious Adverse Events (SAE)

  Procedure, 30 Days, and 180 Days Post-Procedure

Study Arms (1)

Patients with lower extremity acute limb ischemia

Device: Indigo Aspiration System

Device: Indigo Aspiration System

Interventions

Indigo Aspiration System DEVICE

Mechanical aspiration thrombectomy with the Indigo Aspiration System.

Patients with lower extremity acute limb ischemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that present with LE ALI who are eligible for mechanical thrombectomy using the Indigo Aspiration System

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (33)

HonorHealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, 85251, United States

RECRUITING

Sharp Memorial Hospital

San Diego, California, 92123, United States

RECRUITING

Community Memorial Hospital

Ventura, California, 93003, United States

RECRUITING

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

RECRUITING

Christiana Care Health Services, Inc.

Newark, Delaware, 19713, United States

RECRUITING

Manatee Memorial Hospital

Bradenton, Florida, 34208, United States

RECRUITING

University of Florida Shands Hospital

Gainesville, Florida, 32608, United States

RECRUITING

Radiology and Imaging Specialists

Lakeland, Florida, 33805, United States

RECRUITING

Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

Miami, Florida, 33176, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

RECRUITING

Community Hospital

Munster, Indiana, 46321, United States

RECRUITING

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Sanger Heart & Vascular Institute

Concord, North Carolina, 28204, United States

RECRUITING

TriHealth Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

RECRUITING

Lexington Medical Center

West Columbia, South Carolina, 29169, United States

RECRUITING

Jackson-Madison County General Hospital

Jackson, Tennessee, 38301, United States

RECRUITING

Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

RECRUITING

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, 75093, United States

RECRUITING

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

RECRUITING

Universitätsklinik Leipzig

Leipzig, 04103, Germany

RECRUITING

Klinikum Stuttgart - Katharinenhospital

Stuttgart, 70174, Germany

RECRUITING

ASST Degli Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Ospedale Policlinico San Martino, Genova

Genoa, Italy

RECRUITING

Lausanne University Hospital

Lausanne, 1005, Switzerland

RECRUITING

Study Officials

• Daniel Clair, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Dierk Scheinert, MD

  Universitätsklinik Leipzig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Mello

CONTACT

+14078108634; mmello@penumbrainc.com

Jemymah Allen

CONTACT

+13109485738; jallen@penumbrainc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: May 18, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (27); AU (1); DE (2); IT (2); CH (1)