REVEAL Study: Vessel Healing After Angioplasty | NCT00799344

Studies
REVEAL Study: Vessel Healing After Angioplasty

NCT00799344

Sponsor

CeloNova BioSciences, Inc.

Status

Completed

Last Update Posted

Jan 16, 2014Estimated

Enrollment

34Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Catania Stent

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

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Oct 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Nov 25, 2008

First Submission Date that Met QC Criteria

Nov 25, 2008

First Posted Date

Nov 27, 2008Estimated

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

Jan 15, 2014

Last Update Posted Date

Jan 16, 2014Estimated

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

To address early vessel healing and thrombus formation after deployment of three distinct groups of stents

Detailed Description

A prospective, randomized study providing new evidences on early vessel healing and thrombus development after stenting with different devices.

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

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stent		Catania Stent	Device: Catania Stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Catania Stent	Device	coronary stent implantation	Stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percentage of "healed stent struts" at 28-32 days		30 days

Secondary Outcomes

Measure	Description	Time Frame
Measurement of neointimal growth on stent struts		30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Lesion length ≤ 20 mm
Two significant short lesions

Exclusion Criteria:

Life expectancy < 1 year
Left ventricular ejection fraction (LVEF) <30%
Chronic kidney disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients that have two significant short lesions

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Corrado Tamburino, MD	Ferrarotto Hospital, University of Catania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ferrarotto Hospital		Catania	Sicily	95124	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20962664	Derived	La Manna A, Prati F, Capodanno D, Di Salvo M, Sanfilippo A, Barrano G, Monaco S, Tamburino C. Head-to-head comparison of early vessel healing by optical coherence tomography after implantation of different stents in the same patient. J Cardiovasc Med (Hagerstown). 2011 May;12(5):328-33. doi: 10.2459/JCM.0b013e3283406428.

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