Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Enrollment
- 10000
- Locations
- 1
- Primary Endpoint
- All-cause mortality
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Drug coated balloon (DCB) is a relatively new technology which allows the treatment of coronary artery disease without permanent implantation of a metallic scaffold (stent) in the coronary artery. It is recommended by international guidelines for the treatment of in-stent restenosis (i.e. when a previously implanted stent in the coronary artery develops narrowings again). Data on patient outcomes of patients treated with DCB for de novo coronary artery disease (narrowings in artery supplying blood to the heart that has not been previously treated with a stent) are limited to relatively small studies. In our institution, DCBs have been used over the last 10 years and we have developed a large clinical database. We intend to compare the outcomes of all our patients treated clinically with DCB vs patients treated with drug eluting stent (DES). We will, incorporate all patients presenting either with myocardial infarction (heart attack) or stable angina. Our main outcomes will be: Primary 1) mortality Secondary 1) cardiac mortality 2) cardiac rehospitalisation3) composite of cardiac mortality and cardiac rehospitalisation
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
All-cause mortality
Time Frame: Through study completion, an average of 10 years
All cause death will be defined as death due to any cause
Secondary Outcomes
- Cardiac mortality - either MI, TVR, Acute Vessel Closure or TLR(Through study completion, an average of 10 years)
- Composite of cardiac death and cardiac rehospitalisation(Through study completion, an average of 10 years)
- Cardiac rehospitalisation(Through study completion, an average of 10 years)