PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System
NCT ID: NCT03124875
Last Updated: 2024-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2017-07-05
2021-01-05
Brief Summary
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Detailed Description
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Thirty-two subjects were enrolled under protocol revisions A, B, C, and D at seven sites in the United States between 5-July-2017 and 8-April-2019.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Treated with the LimFlow System
LimFlow System
Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia.
Interventions
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LimFlow System
Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia.
Eligibility Criteria
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Inclusion Criteria
* Reviewed and approved for eligibility by the Investigator and the Independent Safety Committee (ISC)
Exclusion Criteria
* Severe heart failure, recent MI or stroke
* Significant peripheral edema or infection that may preclude insertion of a prosthesis or significantly impair wound healing
* Known allergies or contraindications to anti platelet therapy or device materials
* Immunodeficiency disorder or immunosuppressant therapy
* Life expectancy \< 12 months
21 Years
95 Years
ALL
No
Sponsors
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LimFlow, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jihad Mustapha, MD
Role: PRINCIPAL_INVESTIGATOR
Metro Health, University of Michigan
Locations
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Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Kaiser Permanente
Honolulu, Hawaii, United States
Metro Health, University of Michigan
Wyoming, Michigan, United States
New Mexico Heart Institute
Albuquerque, New Mexico, United States
Mount Sinai Health System
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Palmetto Health
Columbia, South Carolina, United States
Countries
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References
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Mustapha JA, Saab FA, Clair D, Schneider P. Interim Results of the PROMISE I Trial to Investigate the LimFlow System of Percutaneous Deep Vein Arterialization for the Treatment of Critical Limb Ischemia. J Invasive Cardiol. 2019 Mar;31(3):57-63. doi: 10.25270/jic/18.00340.
Clair DG, Mustapha JA, Shishehbor MH, Schneider PA, Henao S, Bernardo NN, Deaton DH. PROMISE I: Early feasibility study of the LimFlow System for percutaneous deep vein arterialization in no-option chronic limb-threatening ischemia: 12-month results. J Vasc Surg. 2021 Nov;74(5):1626-1635. doi: 10.1016/j.jvs.2021.04.057. Epub 2021 May 18.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ECO-02527-009
Identifier Type: -
Identifier Source: org_study_id
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