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

Leonardo Bolognese, MD

Status and phase: Terminated; Phase 4

Conditions: Myocardial Ischemia

Treatments: Device: DEB+BMS; Device: POBA+DES

Study type: Interventional

Funder types: Other

Identifiers

NCT01637896

Arezzo000

Details and patient eligibility

About

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

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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125 participants in 2 patient groups

DEB+BMS

Experimental group

Description:

drug-eluting balloon predilation and bare metal stent implantation

Treatment:

Device: DEB+BMS

POBA+DES

Active Comparator group

Description:

conventional balloon predilation and drug-eluting stent implantation

Treatment:

Device: POBA+DES