PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System

LimFlow

Status: Completed

Conditions: Critical Limb Ischemia; Chronic Limb-Threatening Ischemia

Treatments: Device: LimFlow System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03124875

ECO-02527-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 21 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Treatment

Experimental group

Description:

Treated with the LimFlow System

Treatment:

Device: LimFlow System