VIBE-assisted DEB Registry

Withdrawn

• Conditions: Coronary Artery Disease
• Interventions: Device: VIBE + drug-eluting balloon

• Registration Number: NCT01411462
• Lead Sponsor: Ospedale Santa Maria Goretti

Brief Summary

VIBER aims at assessing angiographic outcome of drug-eluting balloon angioplasty assisted by the Vascular Imaging Balloon Catheter (VIBE, Volcano, San Diego, CA) device, which integrates a predilation catheter with electronic intravascular ultrasound capabilities.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-08-05
• Study First Posted: 2011-08-08
• Primary Completion: 2011-10
• Study Completion: 2012-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age >18 years
• De novo native vessel lesion
• RVD 2.5 - 4 mm Limited compliance with >3 month DAPT

Exclusion Criteria

• LMCA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VIBE-DEB	VIBE + drug-eluting balloon	-

Primary Outcome Measures

Name	Time	Method
Binary restenosis	6 months	Number of patients with a diameter stenosis \>50% assessed by quantitative coronary angiography

Secondary Outcome Measures

Name	Time	Method
Procedural success	1 day	Number of patients with both post-procedure diameter stenosis \<20% assessed by quantitative coronary angiography and TIMI 3 flow
Major adverse cardiac events	6 months	Number of patients with one of the following events: cardiac death, non-fatal myocardial infarction, target lesion revascularization

Trial Locations

Locations (1)

S.M. Goretti; 🇮🇹 Latina, Italy