Clinical trial NCT00857441: Drug-eluting Balloon in Bifurcations Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronary Artery Disease
Atherosclerosis
Stable Angina
Unstable Angina
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2009-03-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 branch involvement).
2. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Side branch angiographic Late Lumen Loss (expressed in millimeters) measured by Quantitative Coronary Analysis (QCA)
timeFrame: 6 months
Secondary outcomes:
measure: Target vessel failure (TVF)
timeFrame: 6 months
measure: Major Angiographic coronary or cerebral Events (MACCE)
timeFrame: 6 months
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Oost-Limburg Ziekenhuis
city: Leuven
country: Belgium
facility: Gasthuisberg Leuven
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Pieter Stella, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.