LEADERS FREE II Version 1.0 dated 15th July 2016
Research type
Research Study
Full title
A PROSPECTIVE STUDY OF THE BIOFREEDOM™ BIOLIMUS A9™ DRUG COATED STENT IN PATIENTS AT HIGH RISK FOR BLEEDING
IRAS ID
213542
Contact name
Hans-Peter Stoll
Contact email
Sponsor organisation
Biosensors Europe, S.A.
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 7 months, 16 days
Research summary
Atherosclerosis (disease, in which the heart arteries are narrowed due to the build-up of plaques inside these blood vessels) is a major cause of premature death worldwide and an important source of loss of disability-adjusted life years.
Over the past 10 years, an increasing number of patients with diseased heart arteries have been treated with drug eluting stents (DES) to re-open a narrowed artery and allow blood to flow normally. Compared to previously used bare metal stents (BMS), these dramatically reduce the risk of re-narrowing in the artery. DES have a polymer coating and take longer to fully heal inside the artery than BMS. As a consequence, patients have to take two blood thinning tablets for six to 12 months afterwards, which means that DES are not suitable for patients who are at high risk of bleeding. These previously had to receive a less effective BMS.
The BioFreedom BA9™ drug coated stent (DCS) is a new type of DES without a polymer coating: this means that it heals more quickly and allows one of the blood thinning tablets to be stopped after only one month and thus reduces the risk of bleeding in patients.
BioFreedom DCS was demonstrated in the previously conducted LEADERS FREE trial to provide the benefit of reduced risk of re-narrowing of the heart artery and heart attack compared to a bare metal stent while using ultra short term (1 month) treatment by two blood thinning drugs. LEADERS FREE II is intended to confirm the findings of LEADERS FREE.
This clinical study will recruit 1000-1200 patients in about 85 hospitals in Europe and North America suffering from diseased heart arteries and presenting with high risk of bleeding. Patients will be treated by implantation of the CE-marked BioFreedom DCS and will be followed up for 3 years.REC name
West of Scotland REC 5
REC reference
16/WS/0168
Date of REC Opinion
28 Sep 2016
REC opinion
Favourable Opinion