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NCT01411462 Clinical Trial

VIBE-assisted DEB Registry

Coronary Artery Disease Clinical Trial

— VIBER  

Official title:
Vascular Imaging Balloon Catheter-assisted Drug-eluting Balloon Angioplasty Prospective Registry

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01411462
Other study ID # SMG-007
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date August 2011
Est. completion date January 2012

Study information
Verified date February 2020
Source Ospedale Santa Maria Goretti
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2012
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• VIBE + drug-eluting balloon
VIBE before and after durg-eluting balloon angioplasty

Locations
Country Name City State
Italy S.M. Goretti Latina

Sponsors (1)
Lead Sponsor Collaborator
Ospedale Santa Maria Goretti

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Binary restenosis Number of patients with a diameter stenosis >50% assessed by quantitative coronary angiography 6 months
Secondary Procedural success Number of patients with both post-procedure diameter stenosis <20% assessed by quantitative coronary angiography and TIMI 3 flow 1 day
Secondary Major adverse cardiac events Number of patients with one of the following events: cardiac death, non-fatal myocardial infarction, target lesion revascularization 6 months
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