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

NCT ID: NCT06972225

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-31

Study Completion Date

2036-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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DEB

DEB

Intervention Type DEVICE

Use of DEB to treat coronary lesions

Interventions

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DEB

Use of DEB to treat coronary lesions

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Olivier F. Bertrand

OTHER

Sponsor Role lead

Responsible Party

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Olivier F. Bertrand

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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IUCPQ

Québec, Quebec, Canada

Site Status

Countries

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Canada

Central Contacts

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Michele Jadin

Role: CONTACT

418-6568711

Facility Contacts

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Michele Jadin

Role: primary

418-656-8711

References

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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.

Reference Type BACKGROUND
PMID: 17101615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39130710 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32473887 (View on PubMed)

Other Identifiers

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EASY-DEB

Identifier Type: -

Identifier Source: org_study_id

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