Drug-eluting Balloon in Bifurcations Trial

Coronary Artery Disease Clinical Trial

— DEBIUT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857441
• Other study ID #: CRF8025
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 5, 2009
• Last updated: July 16, 2015
• Start date: January 2008
• Est. completion date: January 2015

Study information

• Verified date: July 2015
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Ministry of Health, Welfare and SportNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2015
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Angina, Stable
• Angina, Unstable
• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Stable Angina
• Unstable Angina

Intervention

Device:
• Drug eluting balloon
Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel
• Liberté
Bare metal stent
• PTCA balloon catheter
Percutaneous transluminal coronary angioplasty catheter
• Taxus
Paclitaxel eluting stent

Locations

Country	Name	City	State
Belgium	Oost-Limburg Ziekenhuis	Genk
Belgium	Gasthuisberg Leuven	Leuven
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Side branch angiographic Late Lumen Loss (expressed in millimeters) measured by Quantitative Coronary Analysis (QCA)		6 months	No
Secondary	Target vessel failure (TVF)		6 months	Yes
Secondary	Major Angiographic coronary or cerebral Events (MACCE)		6 months	Yes