Heart outcomes after drug-eluting balloon treatment for coronary blockages
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
This project will see if adults who had coronary angioplasty with drug-eluting balloons have different rates of major heart problems and survival.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Laval University Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT06972225 on ClinicalTrials.gov |
What this trial studies
Researchers will perform a retrospective analysis of an institutional database to identify adults treated with drug-eluting balloons during coronary angioplasty from January 2010 to December 2025. Patients with incomplete post-procedural follow-up data or procedures that used other devices together with drug-eluting balloons will be excluded. Major adverse cardiovascular events (MACE) and vital status will be captured with prospective follow-up of identified patients. The analysis is single-center and based on routine clinical records from IUCPQ in Québec.
Who should consider this trial
Good fit: Adults (>=18) treated with a drug-eluting balloon at IUCPQ between January 2010 and December 2025 who have available post-procedural follow-up data are the ideal candidates.
Not a fit: Patients without complete follow-up data, those treated with additional devices alongside drug-eluting balloons, or those treated outside IUCPQ or the specified timeframe are unlikely to be included or to benefit from this analysis.
Why it matters
Potential benefit: If successful, this work could clarify safety and longer-term outcomes of drug-eluting balloon treatment to help doctors and patients choose the best option for coronary lesions.
How similar studies have performed: Previous studies of drug-eluting balloons—particularly for in-stent restenosis—have produced mixed but sometimes favorable results, so this analysis builds on existing but not definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Québec, Quebec
- Iucpq — Québec, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Michele Jadin
- Email: michele.jadin@criucpq.ulaval.ca
- Phone: 418-6568711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.