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

Phase 4

Terminated

• Conditions: Myocardial Ischemia
• Interventions: Device: DEB+BMS; Device: POBA+DES

• Registration Number: NCT01637896
• Lead Sponsor: Leonardo Bolognese, MD

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2011-12
• Status Verified: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2012-07-07
• Study First Submitted QC: 2012-07-07
• Study First Posted: 2012-07-11
• Last Update Submitted: 2012-07-11
• Last Update Posted: 2012-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 125

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEB+BMS	DEB+BMS	drug-eluting balloon predilation and bare metal stent implantation
POBA+DES	POBA+DES	conventional balloon predilation and drug-eluting stent implantation

Primary Outcome Measures

Name	Time	Method
angiographic binary re-restenosis	9 months	incidence of angiographic binary re-restenosis

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cardiovascular Department, Ospedale S.Donato; 🇮🇹 Arezzo, AR, Italy