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

Recruiting now

Conditions studied: Lower Extremity Acute Limb Ischemia, LE ALI

In brief

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).

Key facts

Study ID

NCT06747117

Run by

Penumbra Inc.

People needed

300

Starts

2025-05-18

Expected to finish

2029-01-01

Last updated by the study team

2026-08-07

Who can join

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

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

Where it is running

• Emory University Hospital — Atlanta, Georgia, United States (enrolling)
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Mount Sinai Hospital — New York, New York, United States (enrolling)
• UNC Medical Center Hospital — Chapel Hill, North Carolina, United States (enrolling)
• Sanger Heart & Vascular Institute — Concord, North Carolina, United States (enrolling)
• NC Heart and Vascular Research, LLC — Raleigh, North Carolina, United States (enrolling)
• TriHealth Good Samaritan Hospital — Cincinnati, Ohio, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Prisma Health Greenville Memorial Hospital — Greenville, South Carolina, United States (enrolling)
• Lexington Medical Center — West Columbia, South Carolina, United States (enrolling)
• Jackson-Madison County General Hospital — Jackson, Tennessee, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• William P. Clements Jr. University Hospital — Dallas, Texas, United States (enrolling)
• Baylor St. Luke's Medical Center — Houston, Texas, United States (enrolling)
• Baylor Scott & White The Heart Hospital - Plano — Plano, Texas, United States (enrolling)
• The Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
• Flinders Medical Centre — Bedford Park, South Australia, Australia (enrolling)
• Royal North Shore Hospital — Sydney, Australia (enrolling)
• UFMG Hospital Risoleta Tolentino Neves — Belo Horizonte, Brazil (enrolling)
• Universitätsklinik Leipzig — Leipzig, Germany (enrolling)
• Klinikum Stuttgart - Katharinenhospital — Stuttgart, Germany (enrolling)
• ASST Degli Spedali Civili di Brescia — Brescia, Italy (enrolling)
• Ospedale Policlinico San Martino, Genova — Genoa, Italy (enrolling)
• Lausanne University Hospital — Lausanne, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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