Clinical trial NCT00744107: Cobra II Study: Use of the Cobra™ Cobalt Super Alloy Coronary Stent System in the Treatment of Coronary Artery Disease
Official title: The Cobra II Study: Use of the Cobra™ Cobalt Super Alloy Coronary Stent System in the Treatment of Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: 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
Lead sponsor: Medlogics Device Corporation
Sponsor class: INDUSTRY
Collaborators: name: Baim Institute for Clinical Research
name: Stanford University
First posted: 2008-08-29
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: 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.
timeFrame: 270 days
Secondary outcomes:
measure: 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
timeFrame: 30-, 180- and 270-days
Other outcomes:
Locations:
city: Bad Soden
country: Germany
facility: Main Taunus Kliniken, Kardiologisches
city: Essen
country: Germany
facility: St. Vincenz Krankenhaus
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center
city: Eindhoven
country: Netherlands
facility: Catharina-Ziekenhuis
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary
city: Glasgow
country: United Kingdom
facility: Golden Jubilee Hospital
Study officials:
affiliation: Main Taunus Kliniken, Kardiologisches
name: Prof. Nicolaus J Reifart, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: