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PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System

Critical Limb Ischemia Clinical Trial

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

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

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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