Coronary Artery DiseasePhase 2/3DEBIUTNCT00857441
Drug-eluting Balloon in Bifurcations Trial
A Phase 2/3 study testing Drug eluting balloon, Liberté and PTCA balloon catheter in people with Coronary Artery Disease and Atherosclerosis, run by UMC Utrecht at 3 sites in 2 countries.
Trial summary
The purpose of the DEBIUT study is to assess procedural, clinical and angiographic outcomes of: 1. Provisional T-stenting use for dilation the Paclitaxel-eluting PCI-balloon (DiorTM) in comparison to dilation with a standard balloon prior to the implant of the Liberty Bare Metal Stent in bifurcation lesions (with side… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis, Stable Angina
- What is being tested?
- Drug eluting balloon, Liberté and PTCA balloon catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2008to Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable angina pectoris (CCS class 1,2,3,4) or unstable angina and documented ischemia or silent ischemia
- Patients eligible for coronary revascularisation
- The target bifurcation lesion has a major native coronary artery (>2.5mm) with a stenosis > 50% (on visual assessment) located at a side branch (>2mm)
- Patient must be acceptable for CABG
- De novo lesion
- The main vessel lesion can be covered by one stent (up to 32mm)
- Only one target lesion can be included in the study: other lesions in different vessels are successfully treated before the treatment of the target lesion (residual stenosis <30%, stent well deployed, no residual dissection, normal TIMI flow, no chest pain, ECG unchanged compared to pre-procedural ECG)
- Signed patients informed consent
Who cannot join
- Patient unable to give informed consent
- Patients with a previous PCI in the target vessel
- Patients with in stent restenosis of target lesion
- Left ventricular ejection fraction more than 30%
- Patients with left main disease
- Severe calcifications with an undilatable lesion during balloon predilatation
Show all 15Show fewer
- History of bleeding diathesis
- Untreated significant lesion greater than 50% diameter stenosis remaining proximal or distal to the target intervention.
- Patient has suffered a stroke or TIA within the past 3 months
- Life expectancy < 1 year
- Any major surgery planned or required during the next 6 months
- Acute Myocardial Infarction
- Only one target lesion can be included in the study
- Allergy to contrast and/or required anti-platelet medication
- Patients unwilling to return for follow-up at 6 months
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: A Prospective Three-arm Multi-center Study to Investigate Procedural, Clinical and Angiographic Outcomes Using a Drug Eluting Balloon Versus a Standard Balloon in Combination With a Bare Metal Stent and a DES Stent, Following the Provisional Side Branch T-stenting Approach, in Patients With Complex Lesions
The purpose of the DEBIUT study is to assess procedural, clinical and angiographic outcomes of:
- Provisional T-stenting use for dilation the Paclitaxel-eluting PCI-balloon (DiorTM) in comparison to dilation with a standard balloon prior to the implant of the Liberty Bare Metal Stent in bifurcation lesions (with side branch involvement).
- Comparison of the results above with the results of using a standard balloon prior to provisional T-stenting with the Paclitaxel-eluting stent TaxusTM LibertéTM.
- Being tested
- Drug eluting balloon, Liberté, PTCA balloon catheter, Taxus
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis, Angina, Stable, Angina, Unstable
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
LibertéDevice
Also called Liberté (Boston Scientific)
Bare metal stent
PTCA balloon catheterDevice
Also called Any PTCA catheter
Percutaneous transluminal coronary angioplasty catheter
TaxusDevice
Also called Taxus Liberté (Boston scientific)
Paclitaxel eluting stent
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Use of Dior balloon and implant of Liberté Bare Metal Stent Receives: Device: Drug eluting balloon; Device: Liberté |
| 2 | Active comparator | Use of standard balloon and implant of Liberté Bare Metal Stent Receives: Device: Liberté; Device: PTCA balloon catheter |
| 3 | Active comparator | Use of standard balloon and implant of Taxus Liberté Drug Eluting Stent Receives: Device: PTCA balloon catheter; Device: Taxus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side branch angiographic Late Lumen Loss (expressed in millimeters) measured by Quantitative Coronary Analysis (QCA)
Measured: 6 months
Secondary outcomes (2)
Target vessel failure (TVF)
Measured: 6 months
Major Angiographic coronary or cerebral Events (MACCE)
Measured: 6 months
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 startJan 2008
- Primary completionSep 2009
- Study completionJan 2015
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
- 120 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
- NCT00857441
- Sponsor's protocol ID
- CRF8025
- Acronym
- DEBIUT
- Status last verified
- Jul 2015
- First submitted
- 5 Mar 2009
- Last updated
- 20 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Belkacemi A, Agostoni P, Voskuil M, Stella PR. Coronary bifurcation lesions treated with the drug-eluting balloon: a preliminary insight from the DEBIUT study. EuroIntervention. 2011 May;7 Suppl K:K66-9. doi: 10.4244/EIJV7SKA12.
PubMed 22027731
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Three-arm Multi-center Study to Investigate Procedural, Clinical and Angiographic Outcomes Using a Drug Eluting Balloon Versus a Standard Balloon in Combination With a Bare Metal Stent and a DES Stent, Following the Provisional Side Branch T-stenting Approach, in Patients With Complex Lesions
- ClinicalTrials.gov ID
- NCT00857441
- Acronym / sponsor ID
- DEBIUT / CRF8025
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jan 2015 (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 purpose of the DEBIUT study is to assess procedural, clinical and angiographic outcomes of:
- Provisional T-stenting use for dilation the Paclitaxel-eluting PCI-balloon (DiorTM) in comparison to dilation with a standard balloon prior to the implant of the Liberty Bare Metal Stent in bifurcation lesions (with side branch involvement).
- Comparison of the results above with the results of using a standard balloon prior to provisional T-stenting with the Paclitaxel-eluting stent TaxusTM LibertéTM.
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: LibertéUse of Dior balloon and implant of Liberté Bare Metal Stent |
| 2 | Active comparator | Device: Liberté, Device: PTCA balloon catheterUse of standard balloon and implant of Liberté Bare Metal Stent |
| 3 | Active comparator | Device: PTCA balloon catheter, Device: TaxusUse of standard balloon and implant of Taxus Liberté Drug Eluting Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Stable angina pectoris (CCS class 1,2,3,4) or unstable angina and documented ischemia or silent ischemia
- Patients eligible for coronary revascularisation
- The target bifurcation lesion has a major native coronary artery (>2.5mm) with a stenosis > 50% (on visual assessment) located at a side branch (>2mm)
- Patient must be acceptable for CABG
- De novo lesion
Key exclusion criteria (15 listed)
- Patient unable to give informed consent
- Patients with a previous PCI in the target vessel
- Patients with in stent restenosis of target lesion
- Left ventricular ejection fraction more than 30%
- Patients with left main disease
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 |
| LibertéAlso: Liberté (Boston Scientific)Bare metal stent | Device | 1, 2 |
| PTCA balloon catheterAlso: Any PTCA catheterPercutaneous transluminal coronary angioplasty catheter | Device | 2, 3 |
| TaxusAlso: Taxus Liberté (Boston scientific)Paclitaxel eluting stent | Device | 3 |
Primary outcome
Side branch angiographic Late Lumen Loss (expressed in millimeters) measured by Quantitative Coronary Analysis (QCA)
Time frame: 6 months
2 secondary outcomes
Target vessel failure (TVF)
Time frame: 6 months
Major Angiographic coronary or cerebral Events (MACCE)
Time frame: 6 months
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 20 Jul 2015.
- Derived from this study: PubMed 22027731Belkacemi A, Agostoni P, Voskuil M, Stella PR. Coronary bifurcation lesions treated with the drug-eluting balloon: a preliminary insight from the DEBIUT study. EuroIntervention. 2011 May;7 Suppl K:K66-9. doi: 10.4244/EIJV7SKA12.
Related trials for Coronary Artery Disease
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Not yet recruiting
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
Coronary Artery Disease, De Novo Stenosis Lesion
Not yet recruiting
Out-Patient Proactive Observation With Wearable-Assisted Tracking for Cardiovascular Health Management
Chronic Coronary Syndrome
RecruitingObservational study
Mechanical Dyssynchrony and Microvascular Dysfunction by SPECT
Myocardial Blood Flow Reserve, Mechanical Dyssynchrony
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
3 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, Liberté and PTCA balloon catheter in people with Coronary Artery Disease and Atherosclerosis, run by UMC Utrecht at 3 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 8 inclusion and 15 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 20 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, 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?
Side branch angiographic Late Lumen Loss (expressed in millimeters) measured 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 NCT00857441, 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 20 Jul 2015.