Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty

December 15, 2023 updated by: Norfolk and Norwich University Hospitals NHS Foundation Trust

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Recruiting
        • Norfolk and Norwich University Hospitals NHS Foundation Trust
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ioannis Merinopoulos, MRCP
        • Sub-Investigator:
          • Tharusha Gunawardena, MRCP
        • Sub-Investigator:
          • Upul Wickramarachchi, MRCP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients at Norfolk and Norwich University Hospitals NHS foundation trust

Description

Patients with coronary artery disease being treated with DCB or DES

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DCB
DCB group: Patients treated with drug coated balloon (DCB) only angioplasty (all-comers: STEMI, NSTEMI, Stable angina)
Procedure: DCB
Angioplasty with DCB is an angioplasty technique which allows drug delivery to the coronary artery without stent implantation.
DES
DES group: Patients treated with drug eluting stent (DES) angioplasty (all-comers:STEMI, NSTEMI, Stable angina)
Procedure: DES
Angioplasty with DES is an angioplasty technique which permits drug delivery to the coronary artery and permanent implantation of a stent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac mortality - either MI, TVR, Acute Vessel Closure or TLR
Time Frame: Through study completion, an average of 10 years

An MI is defined as per MINAP definition (a hospital diagnosis reported as a troponin positive MI). A TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The latter is defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.

Acute vessel closure is defined as an event where a patient had to be taken back to cardiac catheterisation lab and require repeat angioplasty (during the same hospital stay) for a complete or partial occlusion of the artery due to a dissection.

A TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal and 5 mm distal to the treated lesion (by visual assessment).
Through study completion, an average of 10 years
Cardiac rehospitalisation
Time Frame: Through study completion, an average of 10 years
Any hospital record of admission due to cardiac complications
Through study completion, an average of 10 years
Composite of cardiac death and cardiac rehospitalisation
Time Frame: Through study completion, an average of 10 years
Any hospital record of admission and death due to cardiac complications
Through study completion, an average of 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norfolk and Norwich University Hospitals NHS Foundation Trust

Collaborators

University of East Anglia

Investigators

  • Principal Investigator: Simon C Eccleshall, Norfolk and Norwich University Hospitals NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2017

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 15, 2020

First Submitted That Met QC Criteria

July 21, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Estimated)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 195002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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