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Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty

NCT04482972 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2023-12-18

No results posted yet for this study

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

Conditions

Interventions

PROCEDURE

DCB

Angioplasty with DCB is an angioplasty technique which allows drug delivery to the coronary artery without stent implantation.

PROCEDURE

DES

Angioplasty with DES is an angioplasty technique which permits drug delivery to the coronary artery and permanent implantation of a stent.

Sponsors & Collaborators

  • University of East Anglia

    collaborator OTHER

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Simon C Eccleshall · Norfolk and Norwich University Hospitals NHS Foundation Trust

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-11
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04482972 on ClinicalTrials.gov