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Cobra II Study: Use of the Cobra™ Cobalt Super Alloy Coronary Stent System in the Treatment of Coronary Artery Disease
This study is currently recruiting participants.
Verified by Medlogics Device Corporation, January 2009
Sponsors and Collaborators: Medlogics Device Corporation
Harvard Clinical Research Institute (HCRI)
Stanford University
Information provided by: Medlogics Device Corporation
ClinicalTrials.gov Identifier: NCT00744107
  Purpose

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

MedlinePlus related topics: Coronary Artery Disease
Drug Information available for: Cobalt
U.S. FDA Resources
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

Further study details as provided by Medlogics Device Corporation:

Primary Outcome Measures:
  • 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. [ Time Frame: 270 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MACE defined as all-cause death, MI, emergent CABG, or clinically driven TLR; TVF; 6 month In-segment %DS, late lumen loss, binary restenosis and In-stent %DS,late lumen loss, binary restenosis, MLD [ Time Frame: 30-, 180- and 270-days ] [ Designated as safety issue: Yes ]

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)
Intervention Details:
    Device: PCI with the Cobra™ Cobalt Super Alloy Coronary Stent System
    stent placement, single-arm study
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is ≥ 18 years old;
  • Subject is eligible for percutaneous coronary intervention (PCI), stent placement, and emergent coronary artery bypass graft (CABG) surgery;
  • Subject has clinical evidence of ischemic heart disease, stable or unstable angina or silent ischemia;
  • The subject has a documented left ventricular ejection fraction (LVEF) ≥ 30%;
  • The subject or legal representative has been informed of the clinical study and the required follow-up procedures and must provide written informed consent using a form that is reviewed and approved by the Institutional Review Board/Ethics Committee (IRB/EC) for the clinical site;
  • Female subjects of childbearing potential must have a negative pregnancy test within 7 days before treatment;
  • Subject must agree to comply with the required follow-up procedures (including antiplatelet regimen) to the best of their ability, be geographically available for all study follow-up procedures and visits and not have a known medical condition that precludes completion of the required follow-up visits;
  • The lesion is either de novo or restenotic (previously unstented) in nature, located in a native coronary artery AND is ≥ 50% and < 100% stenosed by visual estimate or on-line QCA;
  • The target vessel reference diameter ≥ 2.5mm and ≤ 4mm by visual estimate and is appropriate for treatment with available stent diameters of 2.5 mm, to 4.0 mm;
  • The lesion length is ≤ 26 mm and able to accommodate placement of a single stent;
  • The target lesion is a minimum of 15 mm from any previously placed stent; AND
  • The target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow ≥ 2

Exclusion Criteria:

  • The subject has a known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, ticlopidine and clopidogrel, cobalt, nickel, chromium, molybdenum, or a sensitivity to contrast media, which cannot be adequately pre-medicated;
  • A platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a WBC < 3,000 cells/mm³;
  • A creatinine level > 2.5 mg/dL within 7 days prior to the index procedure;
  • Evidence of an acute myocardial infarction (MI) within 72 hours of the intended treatment (defined as: Q wave (QWMI) or any elevation of creatine kinase myocardial-band (CK-MB) isoenzyme elevated above the Institution's upper limit of normal;
  • Any previous PCI (with or without stent) of the target vessel within 30 days prior to the index procedure;
  • Previous stent placement anywhere in the target lesion;
  • Previous drug eluting stent (DES) deployment anywhere in the target vessel;
  • The subject requires staged procedure of any non-target vessel within 30 days post-procedure;
  • The subject requires staged procedure of the target vessel within 9 months post-procedure;
  • The target lesion requires treatment with a device other than PTCA prior to stent placement (including, but not limited to, cutting balloon, directional coronary atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc.;
  • History of a stroke or transient ischemic attack (TIA) within the previous 6 months;
  • Active peptic ulcer or upper gastrointestinal (GI) bleeding within the previous 6 months;
  • History of bleeding diathesis or coagulopathy or will refuse blood transfusions;
  • A known concurrent medical condition resulting in a life expectancy of less than 12 months;
  • Any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to brachytherapy;
  • The subject is currently participating in another investigational device or drug study and has not completed the primary endpoint(s) follow-up phase of that study at least 30 days prior to enrollment in this trial; or interferes with the current trial endpoints; or the subject has previously been enrolled in the study;
  • The subject has a known medical condition that will cause them to be non-compliant with the study protocol or confound the data interpretation;
  • The target vessel has evidence of thrombus or other lesions having a > 60% stenosis by visual estimate or on-line QCA;
  • Target vessel exhibiting multiple lesions with greater than 60% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion based on visual estimate or on-line QCA;
  • The target vessel has evidence (visual or QCA) of excessive tortuosity (two or more 90° bends prior to the target lesion) or is severely calcified; OR
  • The target lesion is in an unprotected left main, involves a side branch vessel having a diameter of > 2.0 mm or is at the aorto-ostial location
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744107

Contacts
Contact: Lisa Bousquette, MS 7075455700 ext 217 lbousquette@medlogicsdc.com
Contact: Jack Thomas, RN, BS 7075455700 ext 253 jthomas@medlogicsdc.com

Locations
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            
Sponsors and Collaborators
Medlogics Device Corporation
Harvard Clinical Research Institute (HCRI)
Stanford University
Investigators
Principal Investigator: Prof. Nicolaus J Reifart, PhD, MD Main Taunus Kliniken, Kardiologisches
  More Information

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

Keywords provided by Medlogics Device Corporation:
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

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Cobalt
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Growth Substances
Physiological Effects of Drugs
Trace Elements
Cardiovascular Diseases
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009