Coronary Artery DiseasePhase 2/3DEB-AMINCT00856765
Drug-eluting Balloon in Acute Myocardial Infarction
A Phase 2/3 study testing Drug eluting balloon, Bare metal stent and Drug eluting stent in people with Coronary Artery Disease and Atherosclerosis, run by UMC Utrecht at 2 sites in 2 countries.
Trial summary
The investigators hypothesize that patients with Acute ST Elevation Myocardial Infarction may benefit from primary angioplasty with use of a drug eluting balloon/bare metal stent combination without impairing the process of normal vascular healing and endothelial function. The goals of this study are: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis, Thrombosis
- What is being tested?
- Drug eluting balloon, Bare metal stent and Drug eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2009to Nov 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STEMI within 12 hours of onset of complaints
- Candidate for primary PCI with stent-implantation
- Successful thrombus aspiration defined by no angiographic signs of thrombus a the site of plaque rupture and TIMI flow more or equal 1
Who cannot join
- Unable to give written informed consent
- Diabetes and Type C- coronary lesion
- Previous PCI or CABG of infarct related vessel
- Left main stenosis more than 50%.
- Triple vessel disease with stenosis more than 50% in 3 epicardial coronary arteries
- Target vessel reference diameter less than 2.5 and more than 4.0 mm
Show all 10Show fewer
- Target lesion length more than 25 mm
- Intolerance for aspirin or clopidogrel
- Life expectancy less than 12 months
- Women with child bearing potential
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Randomized Comparison of Drug Eluting Balloon/Bare Metal Stent Versus Drug Eluting Stent Versus Bare Metal Stent for the Treatment of Patients With Acute ST-elevation Myocardial Infarction
The investigators hypothesize that patients with Acute ST Elevation Myocardial Infarction may benefit from primary angioplasty with use of a drug eluting balloon/bare metal stent combination without impairing the process of normal vascular healing and endothelial function.
The goals of this study are:
- To compare 6-month angiographic outcome after primary angioplasty using drug eluting balloon/bare metal stent combination versus drug eluting stent versus bare metal stent.
- To compare stent apposition and stent endothelialization after primary angioplasty using drug eluting balloon/bare metal stent versus drug eluting stent versus bare metal stent.
- To compare coronary endothelial function after primary angioplasty using drug eluting balloon/bare metal stent versus drug eluting stent versus bare metal stent.
- Being tested
- Drug eluting balloon, Bare metal stent, Drug eluting stent
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug eluting balloonDevice
Also called Dior (EuroCor)
Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel
Bare metal stentDevice
Also called Magic (EuroCor)
Bare metal stent
Drug eluting stentDevice
Also called Taxus Liberté (Boston scientific)
Paclitaxel eluting stent
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Drug eluting balloon followed immediately by implantation of bare metal stent Receives: Device: Drug eluting balloon; Device: Bare metal stent |
| 2 | Active comparator | Drug eluting stent Receives: Device: Drug eluting stent |
| 3 | Active comparator | Bare metal stent Receives: Device: Bare metal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA)
Measured: 6 months
Secondary outcomes (4)
Binary restenosis using QCA
Measured: 6 months
stent malapposition and re-endothelialization assessed by Optical Coherence Tomography (OCY)
Measured: 6 months
coronary endothelial dysfunction after acetylcholine infusion
Measured: 6 months
Clinical outcomes (death, myocardial infarction, repeated revascularization procedures)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2011
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Pieter Stella, UMC Utrecht
- Investigators
- Pieter Stella, MD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856765
- Sponsor's protocol ID
- METC 08-255
- Acronym
- DEB-AMI
- Status last verified
- May 2017
- First submitted
- 5 Mar 2009
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Belkacemi A, Agostoni P, Nathoe HM, Voskuil M, Shao C, Van Belle E, Wildbergh T, Politi L, Doevendans PA, Sangiorgi GM, Stella PR. First results of the DEB-AMI (drug eluting balloon in acute ST-segment elevation myocardial infarction) trial: a multicenter randomized comparison of drug-eluting balloon plus bare-metal stent versus bare-metal stent versus drug-eluting stent in primary percutaneous coronary intervention with 6-month angiographic, intravascular, functional, and clinical outcomes. J Am Coll Cardiol. 2012 Jun 19;59(25):2327-37. doi: 10.1016/j.jacc.2012.02.027. Epub 2012 Apr 11.
PubMed 22503057
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Drug Eluting Balloon/Bare Metal Stent Versus Drug Eluting Stent Versus Bare Metal Stent for the Treatment of Patients With Acute ST-elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00856765
- Acronym / sponsor ID
- DEB-AMI / METC 08-255
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 6 Mar 2009 (estimated)
- 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.
The investigators hypothesize that patients with Acute ST Elevation Myocardial Infarction may benefit from primary angioplasty with use of a drug eluting balloon/bare metal stent combination without impairing the process of normal vascular healing and endothelial function.
The goals of this study are:
- To compare 6-month angiographic outcome after primary angioplasty using drug eluting balloon/bare metal stent combination versus drug eluting stent versus bare metal stent.
- To compare stent apposition and stent endothelialization after primary angioplasty using drug eluting balloon/bare metal stent versus drug eluting stent versus bare metal stent.
- To compare coronary endothelial function after primary angioplasty using drug eluting balloon/bare metal stent versus drug eluting stent versus bare metal stent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Drug eluting balloon, Device: Bare metal stentDrug eluting balloon followed immediately by implantation of bare metal stent |
| 2 | Active comparator | Device: Drug eluting stentDrug eluting stent |
| 3 | Active comparator | Device: Bare metal stentBare metal stent |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- STEMI within 12 hours of onset of complaints
- Candidate for primary PCI with stent-implantation
- Successful thrombus aspiration defined by no angiographic signs of thrombus a the site of plaque rupture and TIMI flow more or equal 1
Key exclusion criteria (10 listed)
- Unable to give written informed consent
- Diabetes and Type C- coronary lesion
- Previous PCI or CABG of infarct related vessel
- Left main stenosis more than 50%.
- Triple vessel disease with stenosis more than 50% in 3 epicardial coronary arteries
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 |
|---|---|---|
| Drug eluting balloonAlso: Dior (EuroCor)Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel | Device | 1 |
| Bare metal stentAlso: Magic (EuroCor)Bare metal stent | Device | 1, 3 |
| Drug eluting stentAlso: Taxus Liberté (Boston scientific)Paclitaxel eluting stent | Device | 2 |
Primary outcome
Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA)
Time frame: 6 months
4 secondary outcomes
Binary restenosis using QCA
Time frame: 6 months
stent malapposition and re-endothelialization assessed by Optical Coherence Tomography (OCY)
Time frame: 6 months
coronary endothelial dysfunction after acetylcholine infusion
Time frame: 6 months
Clinical outcomes (death, myocardial infarction, repeated revascularization procedures)
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Results publication: PubMed 22503057Belkacemi A, Agostoni P, Nathoe HM, Voskuil M, Shao C, Van Belle E, Wildbergh T, Politi L, Doevendans PA, Sangiorgi GM, Stella PR. First results of the DEB-AMI (drug eluting balloon in acute ST-segment elevation myocardial infarction) trial: a multicenter randomized comparison of drug-eluting balloon plus bare-metal stent versus bare-metal stent versus drug-eluting stent in primary percutaneous coronary intervention with 6-month angiographic, intravascular, functional, and clinical outcomes. J Am Coll Cardiol. 2012 Jun 19;59(25):2327-37. doi: 10.1016/j.jacc.2012.02.027. Epub 2012 Apr 11.
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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. This study is not recruiting at the moment.
Pieter Stella, MD principal investigator
UMC Utrecht
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Drug eluting balloon, Bare metal stent and Drug eluting stent in people with Coronary Artery Disease and Atherosclerosis, run by UMC Utrecht at 2 sites in 2 countries.
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 10 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: finished, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Netherlands. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA) (time frame: 6 months). 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 NCT00856765, which also lists 1 linked publication.
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 2 May 2017.