VIBE-assisted DEB Registry | NCT01411462

Studies
VIBE-assisted DEB Registry

NCT01411462

Sponsor

Ospedale Santa Maria Goretti

Status

Withdrawn

Last Update Posted

Feb 25, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

VIBE + drug-eluting balloon

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding issues

Expanded Access Info

Start Date

Aug 2011Estimated

Primary Completion Date

Oct 2011Estimated

Completion Date

Jan 2012Actual

First Submitted Date

Aug 3, 2011

First Submission Date that Met QC Criteria

Aug 5, 2011

First Posted Date

Aug 8, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2020

Last Update Posted Date

Feb 25, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VIBE-DEB			Device: VIBE + drug-eluting balloon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VIBE + drug-eluting balloon	Device	VIBE before and after durg-eluting balloon angioplasty	VIBE-DEB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Binary restenosis	Number of patients with a diameter stenosis >50% assessed by quantitative coronary angiography	6 months

Secondary Outcomes

Measure	Description	Time Frame
Procedural success	Number of patients with both post-procedure diameter stenosis <20% assessed by quantitative coronary angiography and TIMI 3 flow	1 day
Major adverse cardiac events	Number of patients with one of the following events: cardiac death, non-fatal myocardial infarction, target lesion revascularization

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with symptomatic coronary artery disease

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided