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A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation (ELICOPTER)

This study has been terminated.
(the study was halted after an interim analysis perfomed for a perceived excess of target vessel revascularization in the DEB+BMS arm)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01637896
First Posted: July 11, 2012
Last Update Posted: July 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato
  Purpose
The purpose of this study is to evaluate the efficacy of predilation with paclitaxel-eluting balloon and bare metal stent implantation VS conventional balloon and drug-eluting stent implantation in terms of restenosis

Condition Intervention Phase
Myocardial Ischemia Device: DEB+BMS Device: POBA+DES Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation: the ELICOPTER Trial

Resource links provided by NLM:


Further study details as provided by Leonardo Bolognese, MD, Ospedale San Donato:

Primary Outcome Measures:
  • angiographic binary re-restenosis [ Time Frame: 9 months ]
    incidence of angiographic binary re-restenosis


Secondary Outcome Measures:
  • Late luminal loss [ Time Frame: 9 months ]
    incidence of late luminal loss assessed by angiography

  • major adverse cardiac events [ Time Frame: 12 months ]
    incidence of major adverse cardiac events


Enrollment: 125
Study Start Date: June 2010
Study Completion Date: July 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DEB+BMS
drug-eluting balloon predilation and bare metal stent implantation
Device: DEB+BMS
drug-eluting balloon predilation and bare metal stent implantation
Active Comparator: POBA+DES
conventional balloon predilation and drug-eluting stent implantation
Device: POBA+DES
conventional balloon predilation and drug-eluting stent implantation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age> 18 years
  • angina or stress test positive for ischemia
  • de novo coronary stenosis>50%

Exclusion Criteria:

  • recent myocardial infarction (<72h)
  • severe chronic kidney disease
  • allergy to Paclitaxel
  • contraindication for combined antiplatelet treatment
  • life expectancy <1 year
  • hypersensitivity or contraindication to one of the study drugs
  • lack of consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637896


Locations
Italy
Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy, 52100
Sponsors and Collaborators
Leonardo Bolognese, MD
Investigators
Principal Investigator: Leonardo Bolognese, MD San Donato Hospital
  More Information

Responsible Party: Leonardo Bolognese, MD, Director, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT01637896     History of Changes
Other Study ID Numbers: Arezzo000
First Submitted: July 7, 2012
First Posted: July 11, 2012
Last Update Posted: July 12, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action