EVOLVE: A Prospective Randomized Multicenter Single-blind Non-inferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System (Evolution Stent System) for the Treatment of a De Novo Atherosclerotic Lesion
EVOLVE: A Prospective Randomized Multicenter Single-blind Non-inferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System (Evolution Stent System) for the Treatment of a De Novo Atherosclerotic Lesion
The purpose of the EVOLVE Trial is to assess the safety and performance of the everolimus-eluting Evolution stent for the treatment of a de novo atherosclerotic lesion of up to 28 mm in length in a native coronary artery 2.25 mm to 3.5 mm in diameter. The safety and performance of two different drug release rate formulations of the Evolution Stent will be compared to the commercially available PROMUS (TM) Element (TM) drug-eluting stent.
Inclusion Criteria:
Exclusion Criteria:
Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI
Patient with unstable angina or recent MI (within 72 hours) must have CK/CK-MB or troponin documented prior to the procedure and are excluded if any of the following criteria are met at the time of the index procedure:
If CK MB >2× upper limit of normal (ULN), the patient is excluded regardless of the CK Total.
If CK Total >2× ULN, either CK-MB or troponin must be drawn and the patient is excluded if either CK-MB or troponin is abnormal.
If neither CK Total or CK MB is drawn but troponin is, the patient is excluded if:
Patient has received an organ transplant or is on a waiting list for an organ transplant
Patient is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
Patient is receiving oral or intravenous immunosuppressive therapy (e.g., inhaled steroids are not excluded ) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
Patient is receiving chronic (≥72 hours) anticoagulation therapy (e.g., heparin, coumadin) for indications other than acute coronary syndrome
Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3
Patient has a white blood cell (WBC) count <3,000 cells/mm3
Patient has documented or suspected liver disease, including laboratory evidence of hepatitis
Patient is on dialysis or has known renal insufficiency (e.g. serum creatinine level >2.0 mg/dL)
Patient has active peptic ulcer disease, an active gastrointestinal (GI) bleed, other bleeding diathesis or coagulopathy, or will refuse transfusions
Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
Target vessel (including side branches) has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index procedure
Target vessel has been treated within 10 mm proximal or distal to the target lesion (by visual estimate) with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to the index procedure
Non-target vessel (including side branches) has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to the index procedure Note: 1 lesion in a non-target vessel may be treated during the index procedure prior to the treatment of the target (study) lesion. The treatment of lesion(s) in non-target vessels more than 24 hours prior to the procedure does not preclude the treatment of an additional non-target lesion during the index procedure. For example, a patient could have an RCA lesion treated 7 days prior to the index procedure and then have a non-target lesion in the LCx and a target lesion in the LAD treated during the index procedure.
Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter immediately prior to stent placement
Planned PCI or CABG after the index procedure
Patient previously treated at any time with coronary intravascular brachytherapy
Patient has a known allergy to the trial stent system or protocol-required concomitant medications (e.g., stainless steel, platinum, chromium, nickel, tungsten, acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be adequately premedicated
Patient has one of the following.
Patient is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
Patient intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
Patient with known intention to procreate within 12 months after the index procedure. (Women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.)
Patient is a woman who is pregnant or nursing. (A pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential.)
Patient has more than 1 target lesion and 1 non-target lesion that will be treated during the index procedure
Angiographic Inclusion criteria (Visual Estimate):
Angiographic Exclusion criteria (visual estimate):
Target lesion meets any of the following criteria.
Patient has unprotected left main coronary artery disease (>50% diameter stenosis)
Patient has protected left main coronary artery disease and a target lesion in the LAD or LCX
Patient has an additional clinically significant lesion(s) in the target vessel for which an intervention within 12 months after the index procedure may be required
Non-target lesion to be treated during the index procedure meets any of the following criteria.