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PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia — PROMISE  

Peripheral Arterial Disease Clinical Trial

Official title:
Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: the PROMISE II Trial

Clinical Trial Summary

The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular treatment option (i.e., "no option").

Clinical Trial Description

The objective of this US pivotal trial is to investigate the safety and effectiveness of The LimFlow System for creating an AV connection in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach to arterialize the pedal veins for the treatment of chronic limb-threatening ischemia (CLTI) in subjects ineligible for conventional endovascular or surgical limb salvage procedures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03970538
Study type Interventional
Source LimFlow, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date December 6, 2019
Completion date February 28, 2025
View Details
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