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Clinical Trials/NCT01411462
NCT01411462WithdrawnNot Applicable

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

Ospedale Santa Maria Goretti1 site in 1 countryStarted: August 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
1
Primary Endpoint
Binary restenosis
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Binary restenosis

Time Frame: 6 months

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

Secondary Outcomes

  • Procedural success(1 day)
  • Major adverse cardiac events(6 months)

Investigators

Sponsor
Ospedale Santa Maria Goretti
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gregory Sgueglia, MD

Dr

Ospedale Santa Maria Goretti

Study Sites (1)

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