Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty

Last updated: December 15, 2023
Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atherosclerosis

Coronary Artery Disease

Chest Pain

Treatment

DES

DCB

Clinical Study ID

NCT04482972
195002
  • Ages 18-100
  • All Genders

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

Eligibility Criteria

Inclusion

Patients with coronary artery disease being treated with DCB or DES

Study Design

Total Participants: 10000
Treatment Group(s): 2
Primary Treatment: DES
Phase:
Study Start date:
September 11, 2017
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    Norwich, Norfolk NR4 7UY
    United Kingdom

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.