Status:
COMPLETED
Drug-eluting Balloon in Bifurcations Trial
Lead Sponsor:
UMC Utrecht
Conditions:
Coronary Artery Disease
Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00857441
Start Date
January 1 2008
End Date
January 1 2015
Last Update
July 20 2015
Active Locations (3)
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1
Oost-Limburg Ziekenhuis
Genk, Belgium
2
Gasthuisberg Leuven
Leuven, Belgium
3
UMC Utrecht
Utrecht, Netherlands, 3584 cx