Drug-eluting Balloon in Bifurcations Trial - Full Text View

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease Atherosclerosis Stable Angina Unstable Angina	Device: Drug eluting balloon Device: Liberté Device: PTCA balloon catheter Device: Taxus	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Angina Atherosclerosis Coronary Artery Disease

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:

Side branch angiographic Late Lumen Loss (expressed in millimeters) measured by Quantitative Coronary Analysis (QCA) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Target vessel failure (TVF) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Major Angiographic coronary or cerebral Events (MACCE) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2018
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Use of Dior balloon and implant of Liberté Bare Metal Stent	Device: Drug eluting balloon Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel Other Name: Dior (EuroCor) Device: Liberté Bare metal stent Other Name: Liberté (Boston Scientific)
Active Comparator: 2 Use of standard balloon and implant of Liberté Bare Metal Stent	Device: Liberté Bare metal stent Other Name: Liberté (Boston Scientific) Device: PTCA balloon catheter Percutaneous transluminal coronary angioplasty catheter Other Name: Any PTCA catheter
Active Comparator: 3 Use of standard balloon and implant of Taxus Liberté Drug Eluting Stent	Device: PTCA balloon catheter Percutaneous transluminal coronary angioplasty catheter Other Name: Any PTCA catheter Device: Taxus Paclitaxel eluting stent Other Name: Taxus Liberté (Boston scientific)

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857441

Locations

Sponsors and Collaborators

UMC Utrecht

Investigators

Principal Investigator:

Pieter Stella, MD

UMC Utrecht

More Information

No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party:	Dr. Pieter Stella, UMC Utrecht
ClinicalTrials.gov Identifier:	NCT00857441 History of Changes
Other Study ID Numbers:	CRF8025
Study First Received:	March 5, 2009
Last Updated:	January 12, 2010
Health Authority:	Netherlands: Ministry of Health, Welfare and Sport Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:

Angina Pectoris
Angina, Unstable
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases

Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 19, 2013

Drug-eluting Balloon in Bifurcations Trial (DEBIUT)