Clinical trial NCT03124875: PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Limb Ischemia
Chronic Limb-Threatening Ischemia
Keywords: Transcatheter Arterialization of Deep Veins
Percutaneous Deep Vein Arterialization
LimFlow System
Lead sponsor: LimFlow, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multi-center pilot study
Primary purpose: TREATMENT

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.

Detailed description: The PROMISE I Trial was a prospective, multi-center, single-arm, investigational feasibility study assessing the LimFlow System for the treatment of chronic- limb-threatening ischemia by creating an arterio-venous fistula in the below-the-knee vasculature. The study was run under an investigational device exemption (IDE G160156, NCT03124875).

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.

Eligibility 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

Primary outcomes:
measure: Amputation-free Survival
timeFrame: 30 days post-procedure
Secondary outcomes:
measure: Amputation-free Survival
timeFrame: 6 months post-procedure
measure: Primary Patency
timeFrame: 30 days post-procedure
measure: Primary Patency
timeFrame: 6 months post-procedure
measure: Secondary Patency
timeFrame: 6 months post-procedure
measure: Limb Salvage
timeFrame: 12 months post-procedure
measure: Wound Healing
timeFrame: 12 months post-procedure
measure: Deterioration in Renal Function
timeFrame: 6 months post-procedure
measure: Technical Success
timeFrame: Post-procedure, immediately
measure: Procedural Success
timeFrame: 30 days post-procedure
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Honolulu
country: United States
facility: Kaiser Permanente
state: Hawaii
city: Wyoming
country: United States
facility: Metro Health, University of Michigan
state: Michigan
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: New York
country: United States
facility: Mount Sinai Health System
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbia
country: United States
facility: Palmetto Health
state: South Carolina
Study officials:
affiliation: Metro Health, University of Michigan
name: Jihad Mustapha, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.