PE PREMIER CHINA CLINICAL TRIAL

Launched by BOSTON SCIENTIFIC CORPORATION · Sep 2, 2014

Keywords

ClinConnect Summary

To evaluate clinical and peri-procedural angiographic outcomes for the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System in 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)

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Clinical Inclusion (CI) Criteria
• • CI1. Subject must be at least 18 -75 years of age
• • CI2. 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
• • CI3. Subject is eligible for percutaneous coronary intervention (PCI)
• • CI4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
• • CI5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
• • CI6. Subject is willing to comply with all protocol-required follow-up evaluation
• • CI7. Subject has a left ventricular ejection fraction (LVEF) \>30% as measured within 60 days prior to enrollment
• • Angiographic Inclusion (AI) Criteria (visual estimate)
• • AI1. 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
• • AI2. Target lesion(s) length must be ≤34 mm ( Target lesion(s) length must be ≤28 mm for reference vessel diameter (RVD) = 2.25 mm Target lesion(s)) (by visual estimate)
• • AI3. Target lesion(s) must have visually estimated stenosis ≥50% and \<100% with thrombolysis in Myocardial Infarction (TIMI) flow \>1 and one of the following (stenosis ≥70%, abnormal fractional flow reserve (FFR), abnormal stress test or imaging stress test, or elevated biomarkers) prior to procedure
• • AI4. Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
• • AI5. The first lesion treated must be successfully pre-dilated/pretreated Note: Successful pre-dilatation/pretreatment refers to dilatation with a balloon catheter of appropriate length and diameter, or pretreatment with/or rotational coronary atherectomy, or cutting/scoring balloon with no greater than 50% residual stenosis and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C.
• Exclusion Criteria:
• • Clinical Exclusion (CE) Criteria
• • CE1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with Acute MI (include STEMI and Non- STEMI ) within 1 week
• • CE2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
• • CE3. Subject has received an organ transplant or is on a waiting list for an organ transplant
• • CE4. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
• • CE5. Planned PCI (including staged procedures) or CABG after the index procedure
• • CE6. Subject previously treated at any time with intravascular brachytherapy
• • CE7. Subject has a known allergy to contrast (that cannot be adequately pre-medicated) 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, Clopidogrel , or aspirin)
• CE8. 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 12 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
• • CE9. Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome
• • CE10. Subject with out of range complete blood count (CBC) values that are determined by the study physician to be clinically significant.
• • CE11. Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
• • CE12. Subject is on dialysis or has baseline serum creatinine level \>2.0 mg/dL (177µmol/L)
• • CE13. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
• • CE14. Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
• • CE15. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
• • CE16. Subject has signs or symptoms of active heart failure (i.e., NYHA class IV) at the time of the index procedure
• • CE17. Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
• • CE18. Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
• • CE19. 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)
• • CE20. 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)
• • CE21.Target vessel has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index procedure
• • Angiographic Exclusion (AE) Criteria (visual estimate)
• • AE1. Planned treatment of more than 3 lesions.
• • AE2. Planned treatment of lesions in more than 2 major epicardial vessels
• • AE3. Planned treatment of a single lesion with more than 1 stent
• • AE4. Subject has 2 target lesions in the same vessel that are separated by less than 20 mm (by visual estimate)
• • AE5. Target lesion(s) is located in the left main
• • AE6. 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.
• • AE7. Target lesion(s) is located within a saphenous vein graft or an arterial graft
• • AE8. Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
• • AE9. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
• • AE10. Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
• • AE11. Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent
• • AE12. Subject has unprotected left main coronary artery disease (\>50% diameter stenosis)
• • AE13. 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
• • AE14. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)
• • AE15. Excessive tortuosity proximal to or within the lesion
• • AE16. Excessive angulation proximal to or within the lesion
• • AE17. Target lesion and/or the target vessel proximal to the target lesion is moderately to severely calcified by visual estimate
• • AE18. Involves a side branch ≥2.0 mm in diameter by visual estimate or a side branch \<2.0 mm in diameter by visual estimate which requires treatment