Prospective, Randomized, Multicenter Trial to Assess PROMUS™ Element™ Stent

PLATINUM China: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS™ Element™) for the Treatment of a Single De Novo Coronary Artery Lesion

The purpose of this study is to evaluate the safety and effectiveness of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System for the treatment of subjects in China with a single de novo atherosclerotic coronary artery lesion.

A prospective, multi-center, randomized-controlled, single-blind, superiority trial at up to 15 sites in China to enroll 500 subjects (3:1 randomization PROMUS Element to TAXUS Liberté) with a single de novo lesion <38mm in length (by visual estimate) in a native coronary artery ≥2.50mm to ≤4.00 mm in diameter (by visual estimate).

Clinical Inclusion Criteria:

• Subject must be age 18 - 75 years
• 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
• Subject is eligible for percutaneous coronary intervention (PCI)
• Subject has symptomatic coronary artery disease or documented silent ischemia
• Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
• Subject has a left ventricular ejection fraction (LVEF) ≥30% as measured within 60 days prior to enrollment
• Subject is willing to comply with all protocol-required follow-up evaluations

Angiographic Inclusion Criteria:

• Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.50 mm and ≤ 4.00 mm.
• Target lesion length must measure <38 mm (by visual estimate)
• Target lesion must have visually estimated stenosis ≥50% and <100% with Thrombolysis in Myocardial Infarction (TIMI) flow >1.
• Target lesion must be successfully pre-dilated.

Exclusion Criteria:

• Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI

• Subject with unstable angina or recent MI (within 1 week) must have creatine kinase (CK)/ creatine kinase-myoglobin band(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:

  • of CK MB >2× upper limit of normal (ULN), the subject is excluded regardless of the CK Total.

  • If CK Total >2× ULN, either CK-MB or troponin must be drawn and the subject is excluded if either CK-MB or troponin is abnormal.

  • If neither CK Total or CK MB is drawn but troponin is, the subject is excluded if troponin >1× ULN and the subject has at least one of the following:

    • Subject has ischemic symptoms and ECG changes indicative of ongoing ischemia (e.g., >1 mm stent thrombosis (ST) segment elevation or depression in consecutive leads or new left bundle branch block (LBBB)
    • Development of pathological Q waves in the ECG or;
    • Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality Note: Subjects who do not have recent MI or unstable angina must still have CK/CK-MB or troponin drawn prior to the index procedure. However, the results for these subjects do not need to be available prior to the index procedure and there are no exclusion criteria based on these laboratory studies.

• 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

• Subject is receiving oral or intravenous immunosuppressive therapy (Note: use of inhaled steroids does not exclude subjects) or has known life- limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; Note: this does not include diabetes mellitus)

• Subject is receiving chronic (≥72 hours) anticoagulation therapy (e.g., heparin, coumadin) for indications other than acute coronary syndrome

• Subject has a platelet count <100,000 cells/mm3 or >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 serum creatinine level >2.0 mg/dL

• Subject has active peptic ulcer disease, an active gastrointestinal (GI) bleed, other bleeding diathesis or coagulopathy or will refuse transfusions

• Subject 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 has been treated with any type of PCI (e.g., 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 PCI or CABG after the index procedure

• Subject previously treated at any time with coronary intravascular brachytherapy

• Subject has known allergy to the study stent system or protocol-required concomitant medications (e.g., everolimus, paclitaxel or structurally related compounds; fluoropolymers; thienopyridines or aspirin; contrast; acrylic; stainless steel; platinum; chromium; nickel; iron; tungsten) that cannot be adequately premedicated

• Subject has any other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 12 months

• Subject has current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)

• Subject has a planned procedure that may cause non-compliance with the protocol or confound data interpretation

• Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint or 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 month 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 month 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.)

• Subject has more than 1 lesion that requires treatment during the index procedure

Angiographic Exclusion Criteria:

• Target lesion meets any of the following criteria:

  • Left main location
  • Located within 5 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery or Right Coronary Artery (RCA) by visual estimate
  • Located within a saphenous vein graft or an arterial graft
  • Will be accessed via a saphenous vein graft or an arterial graft
  • Involves a side branch ≥2.0 mm in diameter by visual estimate
  • Involves a side branch <2.0 mm in diameter by visual estimate which requires treatment
  • TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
  • Excessive tortuosity proximal to or within the lesion
  • Excessive angulation proximal to or within the lesion
  • Target lesion and/or target vessel proximal to the target lesion is moderately to severely calcified by visual estimate
  • Restenotic from previous intervention
  • Thrombus, or possible thrombus, present in the target vessel
  • Target lesion cannot be covered by a single study stent (unplanned bailout stenting is allowed)

• Subject has unprotected left main coronary artery disease (>50% diameter stenosis)

• Subject has protected left main coronary artery disease (>50% diameter stenosis in the left main coronary artery (LMCA) with bypass graft[s] to the left coronary artery) and a target lesion in the LAD or LCX

• Subject has an additional clinically significant lesion(s) for which an intervention within 12 months after the index procedure may be required