the evolve ii clinical trial to assess the synergy stent system for the treatment of atherosclerotic lesion(s)

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to assess the safety and effectiveness of the synergy everolimus-eluting platinum chromium coronary stent system for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

a concurrent, non-randomized, single-arm, pharmacokinetic (pk) substudy and a consecutive, non-randomized, single-arm, diabetes substudy will also enroll under the evolve ii protocol.

Eligibility criteria:
inclusion criteria: * subject must be at least 18 years of age * subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed * for subjects less than 20 years of age enrolled at a japanese site, the subject and the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed * subject is eligible for percutaneous coronary intervention (pci) * subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia * subject is an acceptable candidate for coronary artery bypass grafting (cabg) * subject is willing to comply with all protocol-required follow-up evaluation angiographic inclusion criteria (visual estimate): * target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (rvd) ≥2.25 mm and ≤4.0 mm * target lesion(s) length must be ≤34 mm (by visual estimate) * target lesion(s) must have visually estimated stenosis ≥50% and \ 1 and one of the following: stenosis ≥70%, abnormal fractional flow reserve (ffr), abnormal stress or imaging stress test, or elevated biomarkers prior to the procedure * coronary anatomy is likely to allow delivery of a study device to the target lesions(s) * the first lesion treated must be successfully predilated/pretreated exclusion criteria: * subject has clinical symptoms and/or electrocardiogram (ecg) changes consistent with acute st elevation mi (stemi) * subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina * subject has received an organ transplant or is on a waiting list for an organ transplant * subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure * planned pci (including staged procedures) or cabg after the index procedure * subject previously treated at any time with intravascular brachytherapy _ subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all p2y12 inhibitors, or aspirin) * subject has one of the following (as assessed prior to the index procedure): * other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months * current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.) * planned procedure that may cause non-compliance with the protocol or confound data interpretation * subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome * subject has a platelet count \ 700,000 cells/mm3 * subject has a white blood cell (wbc) count \< 3,000 cells/mm3 * subject has documented or suspected liver disease, including laboratory evidence of hepatitis * subject is on dialysis or has baseline serum creatinine level \>2.0 mg/dl (177µmol/l) * subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions * subject has had a history of cerebrovascular accident (cva) or transient ischemic attack (tia) within the past 6 months * subject has an active peptic ulcer or active gastrointestinal (gi) bleeding * subject has severe symptomatic heart failure (i.e., nyha class iv) * subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint * subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure * subject 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) * subject 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) angiographic exclusion criteria (visual estimate): * planned treatment of more than 3 lesions * planned treatment of lesions in more than 2 major epicardial vessels * planned treatment of a single lesion with more than 1 stent * subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate) * target lesion(s) is located in the left main * target lesion(s) is located within 3 mm of the origin of the left anterior descending (lad) coronary artery or left circumflex (lcx) coronary artery by visual estimate * target lesion(s) is located within a saphenous vein graft or an arterial graft * target lesion(s) will be accessed via a saphenous vein graft or arterial graft * target lesion(s) with a timi flow 0 (total occlusion) or timi flow 1 prior to guide wire crossing * target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent) * target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent * subject has unprotected left main coronary artery disease (\>50% diameter stenosis) * subject has been treated with any type of pci (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure * thrombus, or possible thrombus, present in the target vessel (by visual estimate)

Keywords: drug-eluting stents