VIBE-assisted DEB Registry

Vascular Imaging Balloon Catheter-assisted Drug-eluting Balloon Angioplasty Prospective Registry

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01411462

Acronym

VIBER

Enrollment

Registered

2011-08-08

Start date

2011-08-31

Completion date

2012-01-31

Last updated

2020-02-25

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

Conditions

Coronary Artery Disease

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.

Interventions

DEVICEVIBE + drug-eluting balloon

VIBE before and after durg-eluting balloon angioplasty

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* LMCA

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

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