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Clinical Trials/NCT01637896
NCT01637896
Terminated
Phase 4

A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation: the ELICOPTER Trial

Leonardo Bolognese, MD1 site in 1 country125 target enrollmentJune 2010
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ConditionsMyocardial Ischemia

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Myocardial Ischemia
Sponsor
Leonardo Bolognese, MD
Enrollment
125
Locations
1
Primary Endpoint
angiographic binary re-restenosis
Status
Terminated
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
July 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Leonardo Bolognese, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Leonardo Bolognese, MD

Director

Ospedale San Donato

Eligibility 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

Outcomes

Primary Outcomes

angiographic binary re-restenosis

Time Frame: 9 months

incidence of angiographic binary re-restenosis

Secondary Outcomes

  • Late luminal loss(9 months)
  • major adverse cardiac events(12 months)

Study Sites (1)

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