Drug-eluting Balloon in Bifurcations Trial

NCT00857441 | Completed Phase 2 DMC

• 1 other identifier: CRF8025
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of the DEBIUT study is to assess procedural, clinical and angiographic outcomes of:

1. 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. 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.

Conditions

Coronary Artery Disease; Atherosclerosis; Stable Angina; Unstable Angina

Outcome Measures

Primary Outcomes (1)

• Side branch angiographic Late Lumen Loss (expressed in millimeters) measured by Quantitative Coronary Analysis (QCA)

  6 months

Secondary Outcomes (2)

• Target vessel failure (TVF)

  6 months

• Major Angiographic coronary or cerebral Events (MACCE)

  6 months

Study Arms (3)

1

EXPERIMENTAL

Use of Dior balloon and implant of Liberté Bare Metal Stent

Device: Drug eluting balloon; Device: Liberté

2

ACTIVE COMPARATOR

Use of standard balloon and implant of Liberté Bare Metal Stent

Device: Liberté; Device: PTCA balloon catheter

3

ACTIVE COMPARATOR

Use of standard balloon and implant of Taxus Liberté Drug Eluting Stent

Device: PTCA balloon catheter; Device: Taxus

Interventions

Drug eluting balloon DEVICE

Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel

Also known as: Dior (EuroCor)

1

Liberté DEVICE

Bare metal stent

Also known as: Liberté (Boston Scientific)

1; 2

PTCA balloon catheter DEVICE

Percutaneous transluminal coronary angioplasty catheter

Also known as: Any PTCA catheter

2; 3

Taxus DEVICE

Paclitaxel eluting stent

Also known as: Taxus Liberté (Boston scientific)

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (3)

Oost-Limburg Ziekenhuis

Genk, Belgium

Location

Gasthuisberg Leuven

Leuven, Belgium

Location

UMC Utrecht

Utrecht, 3584 cx, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 22027731 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Angina, Stable; Angina, Unstable

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pieter Stella, MD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 6, 2009
• Study Start: January 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: January 1, 2015
• Last Updated: July 20, 2015

Record last verified: 2015-07

Locations

BE (2); NL (1)