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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01637896

Acronym

ELICOPTER

Enrollment

125

Registered

2012-07-11

Start date

2010-06-30

Completion date

2012-07-31

Last updated

2012-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Ischemia

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

Interventions

DEVICEDEB+BMS

drug-eluting balloon predilation and bare metal stent implantation

DEVICEPOBA+DES

conventional balloon predilation and drug-eluting stent implantation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
angiographic binary re-restenosis	9 months	incidence of angiographic binary re-restenosis

Secondary

Measure	Time frame	Description
Late luminal loss	9 months	incidence of late luminal loss assessed by angiography
major adverse cardiac events	12 months	incidence of major adverse cardiac events

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026