ClinicalTrials.Veeva

Menu

Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty

N

Norfolk and Norwich University Hospitals NHS Foundation Trust

Status

Enrolling

Conditions

Coronary Artery Disease

Treatments

Procedure: DCB
Procedure: DES

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

10,000 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Patients with coronary artery disease being treated with DCB or DES

Trial design

10,000 participants in 2 patient groups

DCB
Description:
DCB group: Patients treated with drug coated balloon (DCB) only angioplasty (all-comers: STEMI, NSTEMI, Stable angina)
Treatment:
Procedure: DCB
DES
Description:
DES group: Patients treated with drug eluting stent (DES) angioplasty (all-comers:STEMI, NSTEMI, Stable angina)
Treatment:
Procedure: DES

Trial contacts and locations

1

Loading...

Central trial contact

Vassilios S Vassilious, PhD, FRCP; Simon C Eccleshall, MRCP, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems