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Compile acute (30-day) clinical outcomes data and 9-month angiographic and intravascular ultrasound (IVUS) data for the PROMUS Element™ Everolimus- Eluting Coronary Stent System in the treatment of patients with a single de novo atherosclerotic lesion
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Inclusion criteria
Angiographic Inclusion Criteria:
Exclusion criteria
Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute myocardial infarction (MI)
Patient has had a known diagnosis of recent MI (within 30 days prior to the index procedure) and has elevated enzymes at the time of the index procedure as follows.
Patients are excluded if any of the following criteria are met at the time of the index procedure
If CK Total/CK-MB are not used and Troponin is, the patients are excluded if the following criterion is met at the time of the index procedure.
Troponin >1× ULN with at least one of the following.
Note: For patients who have had a recent MI, CK Total/CK-MB (or Troponin if CK Total/CK-MB are not used) must be documented prior to enrolling the patient
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 (ie, 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 (eg, 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 (i.e., estimated creatinine clearance <50 mL/min by the Cockcroft Gault formula, ie [(140-age)*lean body weight (in kg)]/[plasma creatinine (mg/dL)*72])
Patient has a history of bleeding diathesis or coagulopathy or will refuse blood 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 or side branch has been treated with any type of percutaneous coronary intervention (PCI; eg, 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 (eg, balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to the index procedure
Non-target vessel or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to 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 percutaneous coronary intervention or coronary artery bypass grafting after the index procedure
Patient previously treated at any time with coronary intravascular brachytherapy
Patient has a known allergy to the study stent system or protocol-required concomitant medications (e.g., stainless steel, platinum, cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be adequately premedicated
Patient has active peptic ulcer or active gastrointestinal (GI) bleeding
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
Known intention to procreate within 12 months after the index procedure
Female with positive pregnancy test within 7 days prior to the index procedure (a pregnancy test must be performed in women of child-bearing potential prior to enrollment), or lactating
Patient has more than 1 target lesion or more than 1 target lesion and 1 non-target lesion, identified during screening for intervention
Angiographic Exclusion Criteria:
Target lesion meets any of the following criteria:
Patient has an additional clinically significant lesion(s) in the target vessel for which an intervention within 12 months after the index procedure is likely to be required
Primary purpose
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100 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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