Coronary Arterial Disease (CAD)EASY-DEBNCT06972225
Restrospective Analysis of MACE in Patients Treated With Drug-elluting Balloons.
An observational study of Coronary Arterial Disease (CAD) and Restenosis, Coronary, run by Olivier F. Bertrand at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD), Restenosis, Coronary, Bifurcation Coronary Disease
- What is being tested?
- DEB
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jun 2025to Mar 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Incomplete or non-available data on the post-procedural clinical follow-up
- Procedures where other devices were used in combination with drug-eluting balloons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
IUCPQ
Québec, Quebec, G1V4G5
Michele Jadin, 418-656-8711, michele.jadin@criucpq.ulaval.ca
Olivier F. Bertrand, MD, PhD
About this study
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
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.
- Being tested
- DEB
- Medical subject headings
- Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEBDevice
Use of DEB to treat coronary lesions
| Study group | Role | What they receive |
|---|---|---|
| DEB | Not described Receives: Device: DEB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
defined as:
- Cardiovascular death
- Myocardial infarction
- Target vessel revascularization
- Cerebrovascular event
- Hospitalization due to heart failure
Measured: within 10 years of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start10 Jun 2025
- Primary completionDec 2035 (estimated)
- Study completionMar 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olivier F. Bertrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Olivier F. Bertrand, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972225
- Sponsor's protocol ID
- EASY-DEB
- Acronym
- EASY-DEB
- Status last verified
- Apr 2026
- First submitted
- 6 May 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 17101615Giacoppo 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.
PubMed 39130710Jeger 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.
PubMed 32473887
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06972225
- Acronym / sponsor ID
- EASY-DEB / EASY-DEB
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Olivier F. BertrandUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Mar 2036 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DEB | – | Device: DEB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Incomplete or non-available data on the post-procedural clinical follow-up
- Procedures where other devices were used in combination with drug-eluting balloons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEBUse of DEB to treat coronary lesions | Device | DEB |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Background: PubMed 17101615Scheller 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.
- Background: PubMed 39130710Giacoppo 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.
- Background: PubMed 32473887Jeger 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arterial Disease (CAD) and Restenosis, Coronary, run by Olivier F. Bertrand at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele Jadin (418-6568711, michele.jadin@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (time frame: within 10 years of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06972225, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.