VIBE-assisted DEB Registry (VIBER)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Ospedale Santa Maria Goretti.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014