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

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

sites

Medstart Washington Hospital Center

Washington, District of Columbia 20010

Principal Investigator: Nelson Bernardo, MD

Phone: 202-877-8475

from

Washington,