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

Myocardial Ischemia Clinical Trial

— ELICOPTER  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01637896
• Other study ID #: Arezzo000
• Status: Terminated
• Phase: Phase 4
• First received: July 7, 2012
• Last updated: July 11, 2012
• Start date: June 2010
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Ospedale San Donato
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 125
• Est. completion date: July 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Device:
• DEB+BMS
drug-eluting balloon predilation and bare metal stent implantation
• POBA+DES
conventional balloon predilation and drug-eluting stent implantation

Locations

Country	Name	City	State
Italy	Cardiovascular Department, Ospedale S.Donato	Arezzo	AR

Sponsors (1)

Lead Sponsor	Collaborator
Leonardo Bolognese, MD

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	angiographic binary re-restenosis	incidence of angiographic binary re-restenosis	9 months	No
Secondary	Late luminal loss	incidence of late luminal loss assessed by angiography	9 months	No
Secondary	major adverse cardiac events	incidence of major adverse cardiac events	12 months	No