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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:
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato
ClinicalTrials.gov Identifier:
NCT01637896
First received: July 7, 2012
Last updated: July 11, 2012
Last verified: July 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by Ospedale San Donato:

Primary Outcome Measures:
  • angiographic binary re-restenosis [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    incidence of angiographic binary re-restenosis


Secondary Outcome Measures:
  • Late luminal loss [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    incidence of late luminal loss assessed by angiography

  • major adverse cardiac events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Leonardo Bolognese, MD, Director, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT01637896     History of Changes
Other Study ID Numbers: Arezzo000
Study First Received: July 7, 2012
Last Updated: July 11, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Diethylstilbestrol
Paclitaxel
Estrogens, Non-Steroidal
 Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013