NCT03124875

PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: LimFlow, Inc. · Industry
• Sex: All
• Age: 21 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Limb Ischemia
• Chronic Limb-Threatening Ischemia

Interventions

Type	Name	Description
DEVICE	LimFlow System	Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia.

Timeline

• Start date: 2017-07-05
• Primary completion: 2019-08-08
• Completion: 2021-01-05
• First posted: 2017-04-24
• Last updated: 2024-05-21
• Results posted: 2024-05-21

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study