The ATLANTA First in Man Study of the Catania Stent - Full Text View

Sponsored by:	CeloNova BioSciences, Inc.
Information provided by:	CeloNova BioSciences, Inc.
ClinicalTrials.gov Identifier:	NCT00799032

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Device: PCI	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Further study details as provided by CeloNova BioSciences, Inc.:

Primary Outcome Measures:

Procedural success, Target Lesion Revascularization, Target Vessel Revascularization, Stent Thrombosis, Cardiac death, fatal/non fatal MI [ Time Frame: In Hospital ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Any death, cardiac death, stent related fatal / non fatal Myocardial Infarction, Target Lesion Revascularization, Target Vessel Revascularization, Stent Thrombosis, Binary Restenosis [ Time Frame: 1 and 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	55
Study Start Date:	May 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stent Catania Stent	Device: PCI coronary stent implantation

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.

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799032

Locations

Italy, Sicily
Ferrarotto Hospital
Catania, Sicily, Italy, 95124

Sponsors and Collaborators

CeloNova BioSciences, Inc.

Investigators

Principal Investigator:

Corrado Tamburino, MD

Ferrarotto Hospital, University of Catania

More Information

No publications provided

Responsible Party:	Ferrarotto Hospital, University of Catania ( Corrado Tamburino, MD, PhD )
Study ID Numbers:	CL-PC-002
Study First Received:	November 25, 2008
Last Updated:	November 27, 2008
ClinicalTrials.gov Identifier:	NCT00799032 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by CeloNova BioSciences, Inc.:

Coronary Stent

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on September 10, 2009