Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2008-01-31
2015-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Use of Dior balloon and implant of Liberté Bare Metal Stent
Drug eluting balloon
Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel
Liberté
Bare metal stent
2
Use of standard balloon and implant of Liberté Bare Metal Stent
Liberté
Bare metal stent
PTCA balloon catheter
Percutaneous transluminal coronary angioplasty catheter
3
Use of standard balloon and implant of Taxus Liberté Drug Eluting Stent
PTCA balloon catheter
Percutaneous transluminal coronary angioplasty catheter
Taxus
Paclitaxel eluting stent
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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UMC Utrecht
OTHER
Responsible Party
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Prof. Pieter Stella
Professor
Principal Investigators
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Pieter Stella, MD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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Oost-Limburg Ziekenhuis
Genk, , Belgium
Gasthuisberg Leuven
Leuven, , Belgium
UMC Utrecht
Utrecht, , Netherlands
Countries
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References
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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.
Other Identifiers
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CRF8025
Identifier Type: -
Identifier Source: org_study_id
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