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

NCT06972225 | Recruiting

• 1 other identifier: EASY-DEB
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Restenosis, Coronary; Bifurcation Coronary Disease; Coronary Arterial Disease (CAD)

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Events

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

  within 10 years of inclusion

Study Arms (1)

DEB

Device: DEB

Interventions

DEB DEVICE

Use of DEB to treat coronary lesions

DEB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Incomplete or non-available data on the post-procedural clinical follow-up
• Procedures where other devices were used in combination with drug-eluting balloons.

Sponsors & Collaborators

• Olivier F. Bertrand: lead

Study Sites (1)

IUCPQ

Québec, Quebec, G1V4G5, Canada

RECRUITING

Related Publications (3)

• Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.

  PMID: 17101615 BACKGROUND

• Giacoppo D, Saucedo J, Scheller B. Coronary Drug-Coated Balloons for De Novo and In-Stent Restenosis Indications. J Soc Cardiovasc Angiogr Interv. 2023 Mar 30;2(3):100625. doi: 10.1016/j.jscai.2023.100625. eCollection 2023 May-Jun.

  PMID: 39130710 BACKGROUND

• 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.

  PMID: 32473887 BACKGROUND

MeSH Terms

Conditions

Coronary Restenosis

Condition Hierarchy (Ancestors)

Coronary Stenosis; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Michele Jadin

CONTACT

418-6568711; michele.jadin@criucpq.ulaval.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): March 1, 2036
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CA (1)