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Recruiting NCT06972225

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DEB.
Who it may be relevant to
Registry conditions: Coronary Arterial Disease (CAD), Restenosis, Coronary, Bifurcation Coronary Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Device DEB
    Use of DEB to treat coronary lesions

Primary outcome measures

  • Major Adverse Cardiovascular Events [Time frame: within 10 years of inclusion]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Canada · 1 center
  • IUCPQ — Québec

Publications

  • 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
  • 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
  • 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

Identifiers

NCT: NCT06972225 · EASY-DEB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗