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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00857441
Other study ID # CRF8025
Secondary ID
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


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
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