Cobra II Study: Use of the Cobra™ Cobalt Super Alloy Coronary Stent System in the Treatment of Coronary Artery Disease

Study Overview
=================
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.

Official Title
-----------------
The Cobra II Study: Use of the Cobra™ Cobalt Super Alloy Coronary Stent System in the Treatment of Coronary Artery Disease

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: PCI with the Cobra™ Cobalt Super Alloy Coronary Stent System


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PCI with the Cobra™ Cobalt Super Alloy Coronary Stent System|stent placement, single-arm study|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 270 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 30-, 180- and 270-days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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