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Clinical Trials/NCT00857441
NCT00857441CompletedPhase 2

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

UMC Utrecht4 sites in 2 countries120 target enrollmentStarted: January 2008Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
120
Locations
4
Primary Endpoint
Side branch angiographic Late Lumen Loss (expressed in millimeters) measured by Quantitative Coronary Analysis (QCA)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Side branch angiographic Late Lumen Loss (expressed in millimeters) measured by Quantitative Coronary Analysis (QCA)

Time Frame: 6 months

Secondary Outcomes

  • Major Angiographic coronary or cerebral Events (MACCE)(6 months)
  • Target vessel failure (TVF)(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof. Pieter Stella

Professor

UMC Utrecht

Study Sites (4)

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