COBRA SHIELD OCT Study

This is an interventional treatment trial for Stable Angina focused on measuring Stable angina, PCI, Percutaneous Coronary Intervention Read More

Inclusion Criteria:

• Patient >= 18 years old.
• Eligible for percutaneous coronary intervention (PCI).
• Patient provides written informed consent.
• Patient is willing to comply with follow-up evaluation.
• Acceptable candidate for coronary artery bypass graft (CABG) surgery.
• Stable angina pectoris or a positive functional ischemia study.
• Male or non-pregnant female patient
• Patient indicated for elective stenting of up to 2 stenotic lesions in two separate native coronary arteries.
• Reference vessel >=2.5 mm and<= 4.0 mm in diameter by visual estimate.
• Target lesion <=20 mm in length by visual estimate.
• Protected left main lesion with >50% stenosis.
• Target lesion stenosis >= 70% and < 100% by visual estimate OR Target lesion stenosis <70% who meet physiological criteria for revascularization (i.e. positive Fractional Flow Reserve).

Exclusion Criteria:

• Currently enrolled in another investigational device or drug trial.
• Previously enrolled in another stent trial within the prior 2 years.
• ANY planned elective surgery or percutaneous intervention within the subsequent 3 months.
• A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
• The patient requires staged procedure of either the target or any non-target vessel before OCT procedure at 3 months post-procedure.
• The target lesion requires treatment with a device other than percutaneous transluminal coronary angioplasty (PTCA) prior to stent placement.
• Previous drug eluting stent (DES) or bare metal stent (BMS) deployment anywhere in the target vessel.
• Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
• Concurrent medical condition with a life expectancy of less than 12 months.
• Documented left ventricular ejection fraction (LVEF) < 50% at the most recent evaluation.
• Patients with diagnosis of myocardial infarction (MI) within 72 hours (i.e. CK-MB must be returned to normal prior to enrollment) or suspected acute MI at time of enrollment.
• Previous intervention in the target vessel.
• History of cerebrovascular accident or transient ischemic attack in the last 6 months.
• Leukopenia (leukocytes < 3.5 x10^9 / liter).
• Neutropenia (Absolute Neutrophil Count < 1000/mm3) <= 3 days prior to enrollment.
• Thrombocytopenia (platelets < 100,000/mm3) pre-procedure.
• Active peptic ulcer or active GI bleeding.
• History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
• Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy or sensitivity to contrast media, which cannot be adequately pre-medicated.
• Serum creatinine level > 2.0 mg/dl within 7 days prior to index procedure.
• Patients not responsive to Plavix/ aspirin and or unable to tolerate Plavix/ aspirin for 6 month post procedure.
• Patient on or may require anticoagulation therapy within 3 months of index procedure.
• Flow limiting dissections observed on OCT
• Significant tissue prolapse within the stent observed on OCT
• Unprotected left main coronary artery disease
• Target vessel with any 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 quantitative coronary arteriography (QCA).
• Target lesion (or vessel) exhibiting an intraluminal thrombus (occupying > 50% of the true lumen diameter) at any time.
• Lesion location that is aorto-ostial or within 5 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).
• Target lesion with side branches > 2.0mm in diameter.
• Target vessel is excessively tortuous (two bends > 90˚ to reach the target lesion).
• Target lesion is severely calcified.
• Thrombolysis In Myocardial Infarction (TIMI) flow 0 or 1
• Target lesion is in a bypass graft