BIOFLOW-DAPT
Research type
Research Study
Full title
BIOFLOW-DAPT: BIOTRONIK - A Prospective, Randomized, Multi-center Study to Assess the SaFety of the Orsiro Mission Stent compared to the ResoLute Onyx Stent in Subjects at High Risk for Bleeding in combination With 1-month Dual Antiplatelet Therapy.
IRAS ID
273883
Contact name
Marcus Knott
Contact email
Sponsor organisation
Biotronik AG
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 5 months, 0 days
Research summary
BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study.
The study will enroll patients who have a high bleeding risk and who also have coronary artery disease requiring drug-eluting stent implantation.
Subjects will be randomized 1:1 to receive one of two different models of drug-eluting stents, either Orsiro or Resolute Onyx.
1,948 subjects will be enrolled.
After their index procedure, all patients will receive Dual Antiplatelet Therapy (Aspirin + a P2Y12 inhibitor) for 30 days, followed by Single Antiplatelet Therapy (either a P2Y12 inhibitor only or Aspirin only) until 12 months post-procedure.
Follow-ups will be scheduled at 1, 6 and 12 months post-procedure and may be performed by telephone call.
The purpose of the study is to assess the safety of the Orsiro Mission Stent System in subjects at high risk for bleeding, undergoing percutaneous coronary intervention (PCI) followed by 30 days of Dual Antiplatelet Therapy (DAPT). It will achieve this by comparing relevant patient outcomes for Orsiro Mission to those for Resolute Onyx, the safety of which has previously been demonstrated for the same patient group.
Investigators are all experienced interventional cardiologists who already have members of the required patient group in their care.REC name
South East Scotland REC 02
REC reference
20/SS/0045
Date of REC Opinion
13 May 2020
REC opinion
Further Information Favourable Opinion