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

Tracking Information
First Received Date ^ICMJE	August 3, 2011
Last Updated Date	September 9, 2011
Start Date ^ICMJE	August 2011
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: August 5, 2011)	Binary restenosis [ Time Frame: 6 months ] [ Designated as safety issue: No ] Number of patients with a diameter stenosis >50% assessed by quantitative coronary angiography
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01411462 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 5, 2011)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	VIBE-assisted DEB Registry
Official Title ^ICMJE	Vascular Imaging Balloon Catheter-assisted Drug-eluting Balloon Angioplasty Prospective Registry
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients with symptomatic coronary artery disease
Condition ^ICMJE	Coronary Artery Disease
Intervention ^ICMJE	Device: VIBE + drug-eluting balloon VIBE before and after durg-eluting balloon angioplasty
Study Group/Cohort (s)	VIBE-DEB Intervention: Device: VIBE + drug-eluting balloon
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	25
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age >18 years De novo native vessel lesion RVD 2.5 - 4 mm Limited compliance with >3 month DAPT Exclusion Criteria: LMCA
Gender	Both
Ages	18 Years to 90 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01411462
Other Study ID Numbers ^ICMJE	SMG-007
Has Data Monitoring Committee	No
Responsible Party	Dr. Edoardo Pucci, S.M. Goretti
Study Sponsor ^ICMJE	Ospedale Santa Maria Goretti
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Ospedale Santa Maria Goretti
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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