PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Chronic Limb-Threatening Ischemia
Critical Limb Ischemia
Ischemia

Clinical Trial Details

NCT number	NCT03124875
Study type	Interventional
Source	LimFlow, Inc.
Contact
Status	Completed
Phase	N/A
Start date	July 5, 2017
Completion date	January 5, 2021

View Details

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