VIBE-assisted DEB Registry (VIBER)

February 21, 2020 updated by: Gregory Sgueglia, MD, Ospedale Santa Maria Goretti

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Latina, Italy
        • S.M. Goretti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with symptomatic coronary artery disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
VIBE-DEB
Device: VIBE + drug-eluting balloon
VIBE before and after durg-eluting balloon angioplasty

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Santa Maria Goretti

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2011

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

August 3, 2011

First Submitted That Met QC Criteria

August 5, 2011

First Posted (Estimate)

August 8, 2011

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMG-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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