A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)
NCT ID: NCT06747117
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2025-05-18
2029-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with lower extremity acute limb ischemia
Device: Indigo Aspiration System
Indigo Aspiration System
Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Interventions
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Indigo Aspiration System
Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Target thrombus in a saphenous vein bypass graft
* 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
18 Years
ALL
No
Sponsors
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Penumbra Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Clair, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Dierk Scheinert, MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinik Leipzig
Locations
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HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona, United States
Christiana Care Health Services, Inc.
Newark, Delaware, United States
Radiology and Imaging Specialists
Lakeland, Florida, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Community Hospital
Munster, Indiana, United States
University of Maryland
Baltimore, Maryland, United States
TriHealth Good Samaritan Hospital
Cincinnati, Ohio, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
Baylor St. Luke's Medical Center
Houston, Texas, United States
Flinders Medical Centre
Bedford Park, South Australia, Australia
Universitätsklinik Leipzig
Leipzig, , Germany
Countries
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Central Contacts
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Other Identifiers
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CLP 30000
Identifier Type: -
Identifier Source: org_study_id