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VIBE-assisted DEB Registry (VIBER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01411462
Recruitment Status : Unknown
Verified August 2011 by Ospedale Santa Maria Goretti.
Recruitment status was:  Recruiting
First Posted : August 8, 2011
Last Update Posted : September 12, 2011
Sponsor:
Information provided by:
Ospedale Santa Maria Goretti

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.

Condition or disease Intervention/treatment
Coronary Artery Disease Device: VIBE + drug-eluting balloon

Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular Imaging Balloon Catheter-assisted Drug-eluting Balloon Angioplasty Prospective Registry
Study Start Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Binary restenosis [ Time Frame: 6 months ]
    Number of patients with a diameter stenosis >50% assessed by quantitative coronary angiography


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Edoardo Pucci, S.M. Goretti
ClinicalTrials.gov Identifier: NCT01411462     History of Changes
Other Study ID Numbers: SMG-007
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: September 12, 2011
Last Verified: August 2011

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