Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty
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- STATUS
- Recruiting
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- End date
- Dec 31, 2026
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- participants needed
- 10000
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- sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
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
Details
| Condition | Coronary Artery Disease, Coronary Artery Disease, Coronary heart disease |
|---|---|
| Age | 18-100 years |
| Treatment | DCB, DES |
| Clinical Study Identifier | NCT04482972 |
| Sponsor | Norfolk and Norwich University Hospitals NHS Foundation Trust |
| Last Modified on | 19 February 2024 |
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