Drug-eluting Balloon in Bifurcations Trial (DEBIUT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00857441
First received: March 5, 2009
Last updated: January 12, 2010
Last verified: March 2009
  Purpose

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.

Condition Intervention Phase
Coronary Artery Disease
Atherosclerosis
Stable Angina
Unstable Angina
Device: Drug eluting balloon
Device: Liberté
Device: PTCA balloon catheter
Device: Taxus
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Side branch angiographic Late Lumen Loss (expressed in millimeters) measured by Quantitative Coronary Analysis (QCA) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Target vessel failure (TVF) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Major Angiographic coronary or cerebral Events (MACCE) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: January 2008
Estimated Study Completion Date: January 2018
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Use of Dior balloon and implant of Liberté Bare Metal Stent
Device: Drug eluting balloon
Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel
Other Name: Dior (EuroCor)
Device: Liberté
Bare metal stent
Other Name: Liberté (Boston Scientific)
Active Comparator: 2
Use of standard balloon and implant of Liberté Bare Metal Stent
Device: Liberté
Bare metal stent
Other Name: Liberté (Boston Scientific)
Device: PTCA balloon catheter
Percutaneous transluminal coronary angioplasty catheter
Other Name: Any PTCA catheter
Active Comparator: 3
Use of standard balloon and implant of Taxus Liberté Drug Eluting Stent
Device: PTCA balloon catheter
Percutaneous transluminal coronary angioplasty catheter
Other Name: Any PTCA catheter
Device: Taxus
Paclitaxel eluting stent
Other Name: Taxus Liberté (Boston scientific)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857441

Locations
Belgium
Oost-Limburg Ziekenhuis
Genk, Belgium
Gasthuisberg Leuven
Leuven, Belgium
Netherlands
UMC Utrecht
Utrecht, Netherlands, 3584 cx
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Pieter Stella, MD UMC Utrecht
  More Information

No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Pieter Stella, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00857441     History of Changes
Other Study ID Numbers: CRF8025
Study First Received: March 5, 2009
Last Updated: January 12, 2010
Health Authority: Netherlands: Ministry of Health, Welfare and Sport
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Arteriosclerosis
Angina, Stable
Angina, Unstable
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014