Back to resultsThe ATLANTA First in Man Study of the Catania Stent (ATLANTA)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
PCI
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Stent
Eligibility 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
Sites / Locations
- Ferrarotto Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Stent
Arm Description
Catania Stent
Outcomes
Primary Outcome Measures
Procedural success, Target Lesion Revascularization, Target Vessel Revascularization, Stent Thrombosis, Cardiac death, fatal/non fatal MI
Secondary Outcome Measures
Any death, cardiac death, stent related fatal / non fatal Myocardial Infarction, Target Lesion Revascularization, Target Vessel Revascularization, Stent Thrombosis, Binary Restenosis
Full Information
NCT ID
NCT00799032
First Posted
November 25, 2008
Last Updated
June 6, 2017
Sponsor
CeloNova BioSciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00799032
Brief Title
The ATLANTA First in Man Study of the Catania Stent
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
CeloNova BioSciences, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stent
Arm Type
Other
Arm Description
Catania Stent
Intervention Type
Device
Intervention Name(s)
PCI
Other Intervention Name(s)
Catania Stent
Intervention Description
coronary stent implantation
Primary Outcome Measure Information:
Title
Procedural success, Target Lesion Revascularization, Target Vessel Revascularization, Stent Thrombosis, Cardiac death, fatal/non fatal MI
Time Frame
In Hospital
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corrado Tamburino, MD
Organizational Affiliation
Ferrarotto Hospital, University of Catania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ferrarotto Hospital
City
Catania
State/Province
Sicily
ZIP/Postal Code
95124
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
The ATLANTA First in Man Study of the Catania Stent
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