The ATLANTA First in Man Study of the Catania Stent

Phase 1

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: PCI

• Registration Number: NCT00799032
• Lead Sponsor: CeloNova BioSciences, Inc.

Brief Summary

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

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2007-08
• Study Completion: 2008-08
• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-11-26
• Study First Posted: 2008-11-27
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

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

Read More

Exclusion Criteria

• Life expectancy < 1 year
• Left ventricular ejection fraction (LVEF) <30%
• Anti-thrombotic drug intolerance

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stent	PCI	Catania Stent

Primary Outcome Measures

Name	Time	Method
Procedural success, Target Lesion Revascularization, Target Vessel Revascularization, Stent Thrombosis, Cardiac death, fatal/non fatal MI	In Hospital

Secondary Outcome Measures

Name	Time	Method
Any death, cardiac death, stent related fatal / non fatal Myocardial Infarction, Target Lesion Revascularization, Target Vessel Revascularization, Stent Thrombosis, Binary Restenosis	1 and 6 months

Trial Locations

Locations (1)

Ferrarotto Hospital; 🇮🇹 Catania, Sicily, Italy