NCT06972225RecruitingNot Applicable
Follow-up of MACE in Patients Treated With Drug-eluting Balloons Between 2010 and 2025; a Retrospective Study With Prospective Follow-up From an Institutional Database: EASY-drug-eluting Balloons
Olivier F. Bertrand1 site in 1 country1,500 target enrollmentStarted: June 10, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,500
- Locations
- 1
- Primary Endpoint
- Major Adverse Cardiovascular Events
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Incomplete or non-available data on the post-procedural clinical follow-up
- •Procedures where other devices were used in combination with drug-eluting balloons.
Arms & Interventions
DEB
Intervention: DEB (Device)
Outcomes
Primary Outcomes
Major Adverse Cardiovascular Events
Time Frame: within 10 years of inclusion
defined as: * Cardiovascular death * Myocardial infarction * Target vessel revascularization * Cerebrovascular event * Hospitalization due to heart failure
Secondary Outcomes
No secondary outcomes reported
Investigators
Olivier F. Bertrand
MD, PhD
Laval University
Study Sites (1)
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