Drug-eluting Balloon in Bifurcations Trial | NCT00857441

Studies
Drug-eluting Balloon in Bifurcations Trial

NCT00857441

Sponsor

UMC Utrecht

Status

Completed

Last Update Posted

Jul 20, 2015Estimated

Enrollment

120Actual

Phase

Phase 2Phase 3

Conditions

Coronary Artery Disease
Atherosclerosis
Stable Angina
Unstable Angina

Interventions

Drug eluting balloon
Liberté
PTCA balloon catheter
Taxus

Countries

Belgium
Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Jan 2015Actual

First Submitted Date

Mar 5, 2009

First Submission Date that Met QC Criteria

Mar 5, 2009

First Posted Date

Mar 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2015

Last Update Posted Date

Jul 20, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Drug eluting balloon	Device	Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel	1

Measure	Description	Time Frame
Side branch angiographic Late Lumen Loss (expressed in millimeters) measured by Quantitative Coronary Analysis (QCA)		6 months

Measure	Description	Time Frame
Target vessel failure (TVF)		6 months
Major Angiographic coronary or cerebral Events (MACCE)		6 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Pieter Stella, MD	UMC Utrecht	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Oost-Limburg Ziekenhuis		Genk			Belgium
Gasthuisberg Leuven

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22027731	Derived	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.

ID	Term
D003324	Coronary Artery Disease
D050197	Atherosclerosis
D060050	Angina, Stable
D000789	Angina, Unstable

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases