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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Patients with coronary artery disease being treated with DCB or DES

Locations
Other Locations
United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
RECRUITING
Norwich
Contact Information
Primary
Simon C Eccleshall, MRCP, MD
Simon.eccleshall@nnuh.nhs.uk
00441603286286
Backup
Vassilios S Vassilious, PhD, FRCP
v.vassiliou@uea.ac.uk
Time Frame
Start Date: 2017-09-11
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 10000
Treatments
DCB
DCB group: Patients treated with drug coated balloon (DCB) only angioplasty (all-comers: STEMI, NSTEMI, Stable angina)
DES
DES group: Patients treated with drug eluting stent (DES) angioplasty (all-comers:STEMI, NSTEMI, Stable angina)
Sponsors
Leads: Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborators: University of East Anglia

This content was sourced from clinicaltrials.gov

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