Restrospective Analysis of MACE in Patients Treated With Drug-elluting Balloons.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOlivier F. Bertrand

About this trial

Retrospective analysis of data collected in an institutional database of coronary interventions with use of drug-eluting balloons, with a prospective follow-up for major adverse cardiovascular events and living status.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (>=18 years of age)

Who underwent a coronary angioplasty with drug-eluting balloon between January 2010 and December 2025

Identified in the institutional procedure database

Disqualifiers

Incomplete or non-available data on the post-procedural clinical follow-up

Procedures where other devices were used in combination with drug-eluting balloons.

Trial population

Consecutive adult patients registered in the institutional procedural database who underwent a coronary angioplasty with drug-eluting balloons exclusively between January 2010 and December 2025.

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

  • DEB

    Device

    Use of DEB to treat coronary lesions

Treatment groups

1,500 Participants
are divided into 1 treatment group
Group A: DEB1 intervention

Trial outcomes

Primary outcomes

1

Major Adverse Cardiovascular Events

defined as: * Cardiovascular death * Myocardial infarction * Target vessel revascularization * Cerebrovascular event * Hospitalization due to heart failure

Time frame
within 10 years of inclusion

Secondary outcomes

Other outcomes

Sponsors and contacts

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Olivier F. Bertrand

Lead sponsor

Laval University

Sponsor institution