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VIBE-assisted DEB Registry (VIBER)

This study is currently recruiting participants.
Verified August 2011 by Ospedale Santa Maria Goretti
Sponsor:
Information provided by:
Ospedale Santa Maria Goretti
ClinicalTrials.gov Identifier:
NCT01411462
First received: August 3, 2011
Last updated: September 9, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention
Coronary Artery Disease
 Device: VIBE + drug-eluting balloon

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular Imaging Balloon Catheter-assisted Drug-eluting Balloon Angioplasty Prospective Registry

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ospedale Santa Maria Goretti:

Primary Outcome Measures:
  • Binary restenosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of patients with a diameter stenosis >50% assessed by quantitative coronary angiography


Secondary Outcome Measures:
  • Procedural success [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Number of patients with both post-procedure diameter stenosis <20% assessed by quantitative coronary angiography and TIMI 3 flow

  • Major adverse cardiac events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of patients with one of the following events: cardiac death, non-fatal myocardial infarction, target lesion revascularization


Estimated Enrollment: 25
Study Start Date: August 2011
Groups/Cohorts Assigned Interventions
VIBE-DEB Device: VIBE + drug-eluting balloon
VIBE before and after durg-eluting balloon angioplasty

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with symptomatic coronary artery disease

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • LMCA
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411462

Locations
Italy
S.M. Goretti Recruiting
Latina, Italy
Contact: Gregory A. Sgueglia         g.a.sgueglia@gmail.com    
Sponsors and Collaborators
Ospedale Santa Maria Goretti
  More Information

No publications provided

Responsible Party: Dr. Edoardo Pucci, S.M. Goretti
ClinicalTrials.gov Identifier: NCT01411462     History of Changes
Other Study ID Numbers: SMG-007
Study First Received: August 3, 2011
Last Updated: September 9, 2011
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013