PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System

LimFlow, Inc.32 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Critical Limb Ischemia Chronic Limb-Threatening Ischemia

Interventions

LimFlow SystemDEVICE

Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (7)

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

Outcomes

Primary Outcomes

Amputation-free Survival

Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality

Time frame: 30 days post-procedure

Secondary Outcomes

Amputation-free Survival

Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality

Time frame: 6 months post-procedure

Primary Patency

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.

Time frame: 30 days post-procedure

Primary Patency

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.

Time frame: 6 months post-procedure

Secondary Patency

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.

Data from ClinicalTrials.gov

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