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Sponsors and Collaborators: |
Medlogics Device Corporation Harvard Clinical Research Institute (HCRI) Stanford University |
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Information provided by: | Medlogics Device Corporation |
ClinicalTrials.gov Identifier: | NCT00744107 |
To demonstrate the safety and efficacy of the Cobra Cobalt Super Alloy Balloon-Expandable Coronary Stent System for the treatment of de novo and restenotic (previously unstented) lesions in native coronary arteries in subjects with coronary artery disease (CAD) having a reference vessel diameter (RVD) between 2.5 - 4.0 mm and a lesion length ≤ 26 mm amenable to percutaneous coronary intervention (PCI) with a single stent in subjects with symptomatic ischemic heart disease.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Device: PCI with the Cobra™ Cobalt Super Alloy Coronary Stent System |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Cobra II Study: Use of the Cobra™ Cobalt Super Alloy Coronary Stent System in the Treatment of Coronary Artery Disease |
Estimated Enrollment: | 258 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Safety and Efficacy will be demonstrated by the rate of Target vessel failure (TVF), defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 270 days of the post-stent placement procedure.
Additionally, Major Adverse Cardiac Events (MACE)at 30, 180 and 270 days defined as a composite of all-cause death, myocardial infarction (MI) (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) [percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)]will be documented.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa Bousquette, MS | 7075455700 ext 217 | lbousquette@medlogicsdc.com |
Contact: Jack Thomas, RN, BS | 7075455700 ext 253 | jthomas@medlogicsdc.com |
Germany | |
Main Taunus Kliniken, Kardiologisches | Recruiting |
Bad Soden, Germany, 65812 | |
Contact: Prof. Nicolaus J Reifart, MD, PhD | |
Principal Investigator: Prof. Nicolaus J. Reifart, MD, PhD | |
Krankenhaus der Barmherzigen Brüder | Recruiting |
Trier, Germany, 54292 | |
Contact: Karl Eugen Hauptmann, MD | |
Principal Investigator: Karl Eugen Hauptmann, MD | |
St. Vincenz Krankenhaus | Recruiting |
Essen, Germany, 45141 | |
Contact: Rainer Jacksch, MD | |
Principal Investigator: Rainer Jacksch, MD | |
Israel | |
Hadassah Hebrew University Medical Center | Recruiting |
Jerusalem, Israel, 91120 | |
Contact: Chaim Lotan, MD, PhD +972-26777487 Lotan@hadassah.org.il | |
Contact: Refat Jabara, MD +972-2-6778879 rjabara@sjha.org | |
Netherlands | |
Catharina-Ziekenhuis | Recruiting |
Eindhoven, Netherlands, 5623 EJ | |
Contact: Jacques Koolen, MD, PhD | |
Principal Investigator: Jacques Koolen, MD, PhD | |
Turkey | |
Marmara Universitesi Tip Fakultesi Vakfi | Not yet recruiting |
Istanbul, Turkey, 34726 | |
Contact: Mehmet Agirbasli, MD | |
Principal Investigator: Mehmet Agirbasli, MD | |
United Kingdom | |
Royal Infirmary | Not yet recruiting |
Edinburgh, United Kingdom, EH16 4SA | |
Contact: Neal Uren, MD | |
Principal Investigator: Neal Uren, MD | |
Golden Jubilee Hospital | Not yet recruiting |
Glasgow, United Kingdom, G81 4HX | |
Contact: Keith Oldroyd, MD | |
Principal Investigator: Keith Oldroyd, MD |
Principal Investigator: | Prof. Nicolaus J Reifart, PhD, MD | Main Taunus Kliniken, Kardiologisches |
Responsible Party: | Medlogics Device Corporation ( Medlogics Device Corporation ) |
Study ID Numbers: | 59-2004 |
Study First Received: | August 27, 2008 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00744107 |
Health Authority: | Germany: Ethics Commission |
Ischemic coronary artery disease in native coronary arteries Single stent RVD 2.5- 4.0mm Lesion length up to 26mm de novo or previously unstented lesions |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Cobalt Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Growth Substances Physiological Effects of Drugs Trace Elements |
Cardiovascular Diseases Micronutrients Pharmacologic Actions |