LIMFLOW PROMISE UK
Research type
Research Study
Full title
PROMISE UK: Percutaneous Deep Vein Arterialization with the Limflow System
IRAS ID
257662
Contact name
Hany Zayed
Contact email
Sponsor organisation
LimFlow SA
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Patients who are candidates for the LimFlow System within the study have critical limb ischaemia of Rutherford Class 5 or 6 and are not suitable for any further endovascular or surgical intervention. These patients have a very high rate of limb amputation when they reach this "no option" stage where other interventions are not possible. The LimFlow System's foundation is similar in concept to that of surgical bypass surgery to the venous system (surgical deep vein arterialisation) for the peripheral limbs, but without the inherent risks of infection that make surgical bypass clinically not viable for patients who do not have adequate distal arteries and who are very ischaemic. The LimFlow procedure allows a bypass of the occluded peripheral artery by creating an arterio-venous connection to produce the venous arterialisation procedure in the below-the-knee vasculature.
The objective of this post-market study is to collect “real-life” clinical data among a population of patients treated with the commercially-available LimFlow System in order to evaluate the safety and effectiveness of the LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialisation in subjects with critical limb ischaemia. The LimFlow System is designed to create a connection between an artery and a vein located below the knee. This device has received CE-mark which means it has been licenced for clinical use in Europe.REC name
London - Westminster Research Ethics Committee
REC reference
19/LO/0408
Date of REC Opinion
3 May 2019
REC opinion
Further Information Favourable Opinion