Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    10000
  • sponsor
    Norfolk and Norwich University Hospitals NHS Foundation Trust
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Updated on 19 February 2024
See if I qualify
myocardial infarction
infarct
angina pectoris
arterial disease
stable angina
in stent restenosis
stent restenosis

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 18years - 100years
Treatment DCB, DES
Clinical Study IdentifierNCT04482972
SponsorNorfolk and Norwich University Hospitals NHS Foundation Trust
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

b'Patients with coronary artery disease being treated with DCB or DES'
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myocardial infarction
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in stent restenosis
stent restenosis

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