NCT01411462

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

August 3, 2011

Last Update Submit

February 21, 2020

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Binary restenosis

    Number of patients with a diameter stenosis \>50% assessed by quantitative coronary angiography

    6 months

Secondary Outcomes (2)

  • Procedural success

    1 day

  • Major adverse cardiac events

    6 months

Study Arms (1)

VIBE-DEB

Device: VIBE + drug-eluting balloon

Interventions

VIBE + drug-eluting balloonDEVICE

VIBE before and after durg-eluting balloon angioplasty

VIBE-DEB

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with symptomatic coronary artery disease

You may qualify if:

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

You may not qualify if:

  • LMCA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.M. Goretti

Latina, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 3, 2011

First Posted

August 8, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2011

Study Completion

January 1, 2012

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

IT(1)