REVEAL Study: Vessel Healing After Angioplasty

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Catania Stent

• Registration Number: NCT00799344
• Lead Sponsor: CeloNova BioSciences, Inc.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-11-25
• Study First Posted: 2008-11-27
• Primary Completion: 2009-10
• Study Completion: 2009-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-15
• Last Update Posted: 2014-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Lesion length ≤ 20 mm
• Two significant short lesions

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stent	Catania Stent	Catania Stent

Primary Outcome Measures

Name	Time	Method
percentage of "healed stent struts" at 28-32 days	30 days

Secondary Outcome Measures

Name	Time	Method
Measurement of neointimal growth on stent struts	30 days

Trial Locations

Locations (1)

Ferrarotto Hospital; 🇮🇹 Catania, Sicily, Italy