NCT03321552

PROMISE International

Percutaneous Deep Vein Arterialization Post-Market Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: LimFlow SA · Industry
• Sex: All
• Age: 21 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The objective of this post-market study is to evaluate the safety and effectiveness of the LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization in subjects with critical limb ischemia.

Detailed description

This study will investigate the safety and effectiveness of the LimFlow System for creating an arterio-venous fistula in the below-the-knee vascular system using an endovascular, minimally invasive approach for the treatment of critical limb ischemia in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
PROCEDURE	Percutaneous deep vein arterialization	Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
DEVICE	LimFlow System	Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach

Timeline

• Start date: 2017-12-15
• Primary completion: 2025-01-23
• Completion: 2025-01-23
• First posted: 2017-10-25
• Last updated: 2026-01-07
• Results posted: 2026-01-07

Locations

12 sites across 5 countries: Austria, Germany, Netherlands, New Zealand, Singapore