- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00799032
The ATLANTA First in Man Study of the Catania Stent (ATLANTA)
June 6, 2017 updated by: CeloNova BioSciences, Inc.
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sicily
-
Catania, Sicily, Italy, 95124
- Ferrarotto Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Stent
Catania Stent
|
coronary stent implantation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Procedural success, Target Lesion Revascularization, Target Vessel Revascularization, Stent Thrombosis, Cardiac death, fatal/non fatal MI
Time Frame: In Hospital
|
In Hospital
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
August 1, 2007
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
November 25, 2008
First Submitted That Met QC Criteria
November 26, 2008
First Posted (Estimate)
November 27, 2008
Study Record Updates
Last Update Posted (Actual)
June 7, 2017
Last Update Submitted That Met QC Criteria
June 6, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL-PC-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
Seung-Jung ParkCardioVascular Research Foundation, KoreaRecruitingCoronary Stenosis | Coronary Artery Bypass Grafting | Coronary Artery Disease Progression | Percutaneous Coronary RevascularizationKorea, Republic of
Clinical Trials on PCI
-
Charite University, Berlin, GermanyCompletedIschaemic Heart DiseaseGermany
-
Maatschap Cardiologie ZwolleAbbott; Radboudumc Technology Center; Clinical StudiesRecruitingPercutaneous Coronary Revascularisation | Complex Coronary LesionNetherlands
-
ZOLL Circulation, Inc., USACompletedAcute Myocardial InfarctionSlovenia, Poland, Austria, Estonia, Hungary, Serbia, Sweden, United Kingdom
-
Duke UniversityFood and Drug Administration (FDA); Medtronic; Abbott Medical Devices; The Medicines... and other collaboratorsTerminatedPercutaneous Coronary Intervention | Ischemic Symptoms
-
General Hospital of Ningxia Medical UniversityUnknownCarcinoma, Small Cell LungChina
-
Unity Health TorontoUnknownAcute Myocardial InfarctionCanada
-
Shenzhen Raysight Intelligent Medical Technology...Shanghai Zhongshan Hospital; West China Hospital; Shenzhen People's HospitalNot yet recruitingMyocardial Ischemia | Cardiovascular Diseases | Coronary Artery Disease | Coronary Disease | Arteriosclerosis | Vascular Disease OcclusiveChina
-
CoreAalst BVRecruitingCoronary Artery DiseaseDenmark, United Kingdom, Belgium, Italy, Hungary
-
Göteborg UniversitySahlgrenska University Hospital, SwedenWithdrawnStable Angina PectorisSweden
-
Heinrich-Heine University, DuesseldorfPhilips Medical SystemsUnknownCoronary DiseaseGermany