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Trial record 1 of 4 for:    limflow
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PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03124875
Recruitment Status : Active, not recruiting
First Posted : April 24, 2017
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
LimFlow, Inc.

Brief Summary:
This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach for the treatment of Critical Limb Ischemia (CLI) in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Device: LimFlow Stent Graft System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, multi-center pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Investigate Safety, Effectiveness and Feasibility of LimFlow Stent Graft System for Creating an AV Fistula for the Treatment of Critical Limb Ischemia
Actual Study Start Date : June 8, 2017
Estimated Primary Completion Date : June 8, 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: Treatment
Treated with the LimFlow Stent Graft System
Device: LimFlow Stent Graft System
Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia.




Primary Outcome Measures :
  1. Amputation-free survival [ Time Frame: 30 days post-procedure ]
    Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality


Secondary Outcome Measures :
  1. Amputation-free survival [ Time Frame: 6 months post-procedure ]
    Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality

  2. Primary Patency [ Time Frame: 30 days post-procedure ]
    Percentage of patients with absence of total occlusion of the stent graft without prior clinically-driven major re-intervention of the stent graft. Total occlusion is defined as absence of flow on color doppler or angiogram and clinically-driven major re-intervention is defined as creation of a new surgical bypass, use of thrombectomy or thrombolysis, or major surgical revision performed for occlusion of the stent graft.

  3. Primary Patency [ Time Frame: 6 months post-procedure ]
    Percentage of patients with absence of total occlusion of the stent graft without prior clinically-driven major re-intervention of the stent graft.Total occlusion is defined as absence of flow on color doppler or angiogram and clinically-driven major re-intervention is defined as creation of a new surgical bypass, use of thrombectomy or thrombolysis, or major surgical revision performed for occlusion of the stent graft.

  4. Secondary Patency [ Time Frame: 6 months post-procedure ]
    Percentage of patients with absence of total occlusion of the stent graft with or without prior clinically-driven major re-intervention of the stent graft.Total occlusion is defined as absence of flow on color doppler or angiogram and clinically-driven major re-intervention is defined as creation of a new surgical bypass, use of thrombectomy or thrombolysis, or major surgical revision performed for occlusion of the stent graft.

  5. Limb Salvage [ Time Frame: 3, 6, 9, and 12 months post-procedure ]
    Percentage of subjects with freedom from above-ankle amputation of the index limb

  6. Wound Healing [ Time Frame: 3, 6, 9, and 12 months post-procedure ]
    Percentage of subjects with completed index wound healing

  7. Deterioration in Renal Function [ Time Frame: 6 months post-procedure ]
    Percentage of subjects with a 25% increase in serum creatinine after using iodine contrast agents, without another clear cause for kidney injury.

  8. Technical Success [ Time Frame: Post-procedure ]
    Percentage of subjects with completion of the endovascular procedure and immediate morphological success with successful placement of the arterial and venous catheters in the desired location in the limb, and ability to place the stent graft.

  9. Procedural Success [ Time Frame: 30 days post-procedure ]
    Percentage of subjects with a combination of Technical Success and absence of all-cause mortality, above-ankle amputation or clinically driven major re-intervention of the stent graft.



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Ages Eligible for Study:   21 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of critical limb ischemia with hemodynamic evidence of severely diminished arterial inflow of the index limb and Rutherford Classification 5 r 6
  • Reviewed and approved for eligibility by the Investigator and the Independent Safety Committee (ISC)

Exclusion Criteria:

  • Concomitant hepatic or renal insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124875


Locations
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United States, District of Columbia
Medstar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Hawaii
Kaiser Permanente
Honolulu, Hawaii, United States, 96817
United States, Michigan
Metro Health, University of Michigan
Wyoming, Michigan, United States, 49519
United States, New Mexico
New Mexico Heart Institute
Albuquerque, New Mexico, United States, 87102
United States, New York
Mount Sinai Health System
New York, New York, United States, 10029
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, South Carolina
Palmetto Health
Columbia, South Carolina, United States, 29203
Sponsors and Collaborators
LimFlow, Inc.
Investigators
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Principal Investigator: Jihad Mustapha, MD Metro Health, University of Michigan

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Responsible Party: LimFlow, Inc.
ClinicalTrials.gov Identifier: NCT03124875    
Other Study ID Numbers: ECO-02527-009
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes