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NCT00799032 Clinical Trial

The ATLANTA First in Man Study of the Catania Stent

Coronary Artery Disease Clinical Trial

— ATLANTA  

Official title:
Assessment of The Latest Non-Thrombogenic Angioplasty Stent (ATLANTA): Prospective, First in Man, Non-Randomized, Single Center for Patients With Documented Myocardial Ischemia Undergoing PCI

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00799032
Other study ID # CL-PC-002
Secondary ID
Status Completed
Phase Phase 1
First received November 25, 2008
Last updated June 6, 2017
Start date May 2007
Est. completion date August 2008

Study information
Verified date June 2017
Source CeloNova BioSciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date August 2008
Est. primary completion date August 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• PCI
coronary stent implantation

Locations
Country Name City State
Italy Ferrarotto Hospital Catania Sicily

Sponsors (1)
Lead Sponsor Collaborator
CeloNova BioSciences, Inc.

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Procedural success, Target Lesion Revascularization, Target Vessel Revascularization, Stent Thrombosis, Cardiac death, fatal/non fatal MI In Hospital
Secondary 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
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