Pilot Study to Investigate Safety, Effectiveness and Feasibility of LimFlow Stent Graft System



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - 95
Updated:1/19/2019
Start Date:June 8, 2017
End Date:December 2020
Contact:Thomas Engels
Email:Tengels@limflow.com
Phone:888-478-7705

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


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
We found this trial at
7
sites
Metro Health, University of Michigan
5950 Metro Way
Wyoming, Michigan 49519
Principal Investigator: Jihad Mustapha, MD
Phone: 616-252-7316
?
mi
from
Wyoming, MI
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New Mexico Heart Institute
Albuquerque, New Mexico 87102
Principal Investigator: Steve Henao, MD
Phone: 505-843-2802
?
mi
from
Albuquerque, NM
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Harrington Heart and Vascular Institute
Cleveland, Ohio 44106
Principal Investigator: Medhi Shishehbor, MD
Phone: 216-844-3545
?
mi
from
Cleveland, OH
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Palmetto Health
Columbia, South Carolina 29203
Principal Investigator: Daniel Clair, MD
Phone: 803-434-4338
?
mi
from
Columbia, SC
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Kaiser Permanente
Honolulu, Hawaii 96819
?
mi
from
Honolulu, HI
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Mount Sinai Health System
New York, New York 10029
Principal Investigator: John Lantis, MD
Phone: 212-523-5915
?
mi
from
New York, NY
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Medstart Washington Hospital Center
Washington, District of Columbia 20010
Principal Investigator: Nelson Bernardo, MD
Phone: 202-877-8475
?
mi
from
Washington,
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