PROMISE II
Research type
Research Study
Full title
Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: The PROMISE II Trial
IRAS ID
294570
Contact name
Hany Zayed
Contact email
Sponsor organisation
LimFlow SA
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 8 months, 1 days
Research summary
Patients who are candidates for the LimFlow System within the study have chronic limb-threatening 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 non-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 purpose of the PROMISE II study is to collect clinical data among a population of patients treated with the 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. The LimFlow System has received CE-mark which means it has been licenced for clinical use in Europe. The device, however, is currently investigational within the United States and a stated objective of the study is to use the data collected globally to support regulatory approval and adoption of the LimFlow System in the United States.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
21/SW/0050
Date of REC Opinion
14 May 2021
REC opinion
Further Information Favourable Opinion