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Clinical Trials/NCT04482972
NCT04482972
Recruiting
Not Applicable

Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience

Norfolk and Norwich University Hospitals NHS Foundation Trust1 site in 1 country10,000 target enrollmentSeptember 11, 2017

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

Registry
clinicaltrials.gov
Start Date
September 11, 2017
End Date
December 31, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

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)

Study Sites (1)

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