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Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty

NCT ID: NCT04482972

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-11

Study Completion Date

2026-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Coronary Artery Disease

Keywords

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Drug coated balloon Drug eluting stent

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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DCB

DCB group: Patients treated with drug coated balloon (DCB) only angioplasty (all-comers: STEMI, NSTEMI, Stable angina)

DCB

Intervention Type PROCEDURE

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)

DES

Intervention Type PROCEDURE

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

Interventions

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DCB

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

Intervention Type PROCEDURE

DES

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Patients with coronary artery disease being treated with DCB or DES
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of East Anglia

OTHER

Sponsor Role collaborator

Norfolk and Norwich University Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simon C Eccleshall

Role: PRINCIPAL_INVESTIGATOR

Norfolk and Norwich University Hospitals NHS Foundation Trust

Locations

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Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Simon C Eccleshall, MRCP, MD

Role: CONTACT

Phone: 00441603286286

Email: [email protected]

Vassilios S Vassilious, PhD, FRCP

Role: CONTACT

Email: [email protected]

Facility Contacts

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Simon C Eccleshall, MRCP, MD

Role: primary

Vassilious S Vassiliou, PhD, FRCP

Role: backup

References

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Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX; International DCB Consensus Group. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391-1402. doi: 10.1016/j.jcin.2020.02.043. Epub 2020 May 27.

Reference Type BACKGROUND
PMID: 32473887 (View on PubMed)

Merinopoulos I, Corballis N, Gunawardena T, Bhalraam U, Natarajan R, Reinhold J, Wickramarachchi U, Maart C, Sawh C, Sulfi S, Gilbert T, Wistow T, Ryding A, Vassiliou VS, Eccleshall SC. Assessment of Scoring Balloons in STEMI Patients Treated With DCB-Only Angioplasty: A Single Center Study. Health Sci Rep. 2025 May 21;8(5):e70839. doi: 10.1002/hsr2.70839. eCollection 2025 May.

Reference Type DERIVED
PMID: 40406647 (View on PubMed)

Merinopoulos I, Gunawardena T, Corballis N, Bhalraam U, Reinhold J, Wickramarachchi U, Maart C, Gilbert T, Richardson P, Sulfi S, Sarev T, Sawh C, Wistow T, Ryding A, Mohamed MO, Perperoglou A, Mamas MA, Vassiliou VS, Eccleshall SC. Assessment of Paclitaxel Drug-Coated Balloon Only Angioplasty in STEMI. JACC Cardiovasc Interv. 2023 Apr 10;16(7):771-779. doi: 10.1016/j.jcin.2023.01.380.

Reference Type DERIVED
PMID: 37045498 (View on PubMed)

Other Identifiers

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195002

Identifier Type: -

Identifier Source: org_study_id