The ATLANTA First in Man Study of the Catania Stent

NCT ID: NCT00799032

Last Updated: 2017-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-08-31

Brief Summary

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To evaluate the short-term and mid-term safety and efficacy of the Catania coronary stent for the treatment of up to two de novo lesions in native coronary arteries.

Detailed Description

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This is a prospective, non-randomized, first-in-man single center study. The study requires a 55 patients with documented myocardial ischemia undergoing PCI.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stent

Catania Stent

Group Type OTHER

PCI

Intervention Type DEVICE

coronary stent implantation

Interventions

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PCI

coronary stent implantation

Intervention Type DEVICE

Other Intervention Names

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Catania Stent

Eligibility Criteria

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Inclusion Criteria

* Lesion length ≤ 20 mm
* Vessel size ≥ 2.5 ≤ 3.5 mm

Exclusion Criteria

* Life expectancy \< 1 year
* Left ventricular ejection fraction (LVEF) \<30%
* Anti-thrombotic drug intolerance
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CeloNova BioSciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Ferrarotto Hospital, University of Catania

Principal Investigators

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Corrado Tamburino, MD

Role: PRINCIPAL_INVESTIGATOR

Ferrarotto Hospital, University of Catania

Locations

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Ferrarotto Hospital

Catania, Sicily, Italy

Site Status

Countries

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Italy

Other Identifiers

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CL-PC-002

Identifier Type: -

Identifier Source: org_study_id

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