A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System
NCT ID: NCT04144959
Last Updated: 2025-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
119 participants
OBSERVATIONAL
2019-12-17
2023-10-20
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
Indigo Aspiration System
Indigo Aspiration System
Interventions
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Indigo Aspiration System
Indigo Aspiration System
Eligibility Criteria
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Inclusion Criteria
* Patient presents with acute (≤14 days) occlusion of lower limb artery(ies) (below inguinal ligament)
* Patient with a Rutherford Category I, IIa or IIb score
* Frontline treatment with Indigo Aspiration System
* Informed consent is obtained from either patient or legally authorized representative (LAR)
Exclusion Criteria
* Vessel size \<2 mm
* LE ALI secondary to dissections, vasculitis, and/or target vessel trauma
* Amputation in the ipsilateral limb
* Pregnancy or positive pregnancy test according to site specific standards of care (only required for women of child bearing potential, serum or urine acceptable)
* Absolute contraindication to contrast administration
* Patient is unwilling or unable to comply with protocol follow up schedule and/or based on the Investigator's judgment the patient is not a good study candidate
* Currently participating in an investigational drug or device clinical trial that may confound the study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.
18 Years
ALL
No
Sponsors
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Penumbra Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Maldonado, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Medical Center
Locations
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Stanford University Medical Center
Stanford, California, United States
Danbury Hospital
Danbury, Connecticut, United States
Manatee Memorial Hospital
Bradenton, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
University of Maryland
Baltimore, Maryland, United States
Albany Medical Center
Albany, New York, United States
Tisch Hospital NYU Langone Health
New York, New York, United States
NC Heart and Vascular Research
Cary, North Carolina, United States
Sanger Heart & Vascular Institute
Charlotte, North Carolina, United States
Trihealth Good Samaritan Hospital of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Holston Valley Medical
Kingsport, Tennessee, United States
Baylor College of Medicine (St. Luke's Medical Center)
Houston, Texas, United States
Sentara Vascular Specialists
Norfolk, Virginia, United States
Klinikum rechts der Isar
München, , Germany
St. Franziskus-Hospital - Münster
Münster, , Germany
Hospital Clínico Universitario de Santiago
Santiago de Compostela, , Spain
Countries
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References
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Maldonado TS, Powell A, Wendorff H, Rowse J, Nagarsheth KH, Dexter DJ, Dietzek AM, Muck PE, Arko FR, Chung J; STRIDE study group. Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia. J Vasc Surg. 2024 Mar;79(3):584-592.e5. doi: 10.1016/j.jvs.2023.10.062. Epub 2023 Nov 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLP 15549
Identifier Type: -
Identifier Source: org_study_id
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