Target Enrolment:
500 Patients

  • Lead Investigator
    Sandeep Basavarajaiah,
    Heart of England NHS trust,
    Birmingham, UK
STUDY DESIGN

• The purpose of this study is to observe and evaluate the performance of a Sirolimus-eluting Drug-Coated Balloon (SCB) for the treatment of any coronary lesions, including de novo lesions and in- stent restenosis

• A prospective, multicenter, clinical registry that will enroll real world, all comer patients at various interventional cardiology sites in England.

• Clinical follow-up at 1, 6, 12 and 24 months.

Study Endpoints:

Primary Endpoint:
Target vessel failure at 12-months, which will be a combination of cardiac death, target vessel MI and ischaemia target vessel revascularization.

Secondary Endpoint:
Individual components of primary endpoints including target vessel revascularization during follow-up, procedural success and need for bailout stenting post DCB.