PLATINUM Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions-Pharmacokinetics (PLATINUM PK)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: PROMUS Element Everolimus-Eluting Coronary Stent System; Aspirin; Thienopyridine
Intervention description: PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).; Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter.; Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant.
Intervention MeSH terms: Aspirin; Everolimus; Ticlopidine; Clopidogrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: drug-eluting stents; DES; atherosclerotic

Summary:

      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 patients with up to 2 de novo
      atherosclerotic coronary artery lesions. The lesions are located in vessels that are
      average-sized.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must be at least 18 years of age

          -  Patient (or legal guardian) understands study requirements and treatment procedures
             and provides written informed consent before any study-specific tests or procedures
             are performed

          -  For patients less than 20 years of age enrolled at a Japanese site, patient and
             patient's legal representative must provide written informed consent before any
             study-specific tests or procedures are performed

          -  Patient is eligible for percutaneous coronary intervention (PCI)

          -  Patient has documented stable angina pectoris or documented silent ischemia; or
             unstable angina pectoris

          -  Patient is an acceptable candidate for coronary artery bypass grafting (CABG)

          -  Patient has a left ventricular ejection fraction (LVEF) >=30% as measured within 30
             days prior to enrollment

          -  Patient is willing to comply with all protocol-required follow-up evaluations

        Angiographic Inclusion Criteria (visual estimate):

        • 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 <=4.25 mm. Target lesion
        length must measure (by visual estimate) <=24 mm. Target lesion must be in a major coronary
        artery or branch with visually estimated stenosis >=50% and <100% with Thrombolysis in
        Myocardial Infarction (TIMI) flow >1.

        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 (ie, within 72 hours prior to index
             procedure) and has elevated enzymes at time of index procedure as follows.

               -  Patients are excluded if any of the following criteria are met at time of the
                  index procedure.

                    -  If creatine kinase-myoglobin band(CK-MB) >2× upper limit of normal (ULN),
                       the patient is excluded regardless of CK Total.

                    -  If CK-MB is 1-2× ULN, the patient is excluded if the CK Total is >2× ULN.

               -  If CK Total/CK MB are not used and Troponin is, patients are excluded if the
                  following criterion is met at time of index procedure.

                    -  Troponin >1× ULN with at least one of the following.

                    -  Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia
                       (eg, >1 mm 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: For patients with unstable angina or 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/randomizing 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 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 (eg, 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 platelet count <100,000 cells/mm3 or >700,000 cells/mm3

          -  Patient has 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 (ie, estimated creatinine
             clearance <50 ml/min by the Cockcroft Gault formula, or [(140-age)*lean body weight
             (in kg)]/[plasma creatinine (mg/dl)*72])

          -  Patient has history of bleeding diathesis or coagulopathy or will refuse blood
             transfusions

          -  Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA)
             within past 6 months, or has any permanent neurologic defect that may cause
             non-compliance with the protocol

          -  Target vessel(s) or side branch has been treated with any type of PCI (eg, balloon
             angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to index
             procedure

          -  Target vessel(s) has been treated within 10 mm proximal or distal to target lesion (by
             visual estimate) with any type of PCI (eg, balloon angioplasty, stent, cutting
             balloon, atherectomy) at any time prior to 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 index
             procedure

          -  Planned or actual target vessel(s) 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 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 (eg, 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.

               -  Other serious medical illness (eg, cancer, congestive heart failure) that may
                  reduce life expectancy to less than 24 months

               -  Current problems with substance abuse (eg, alcohol, cocaine, heroin, etc.)

               -  Planned procedure that may cause non-compliance with protocol or confound data
                  interpretation

          -  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 index procedure

          -  Patient with known intention to procreate within 12 months after 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 2 target lesions, or more than 1 target lesion and 1 non-target
             lesion, which will be treated during the index procedure

        Angiographic Exclusion Criteria (visual estimate):

          -  Target lesion meets any of the following criteria:

               -  Aorto-ostial location (ie, lesion located within 5 mm of ostium by visual
                  estimate)

               -  Left main location

               -  Located within 5 mm of origin of the left anterior descending (LAD) coronary
                  artery or left circumflex (LCX) coronary artery by visual estimate

               -  Located within a saphenous vein graft or arterial graft

               -  Will be accessed via a saphenous vein graft or arterial graft

               -  Involves a side branch >=2.0 mm in diameter by visual estimate

               -  Involves a clinically significant side branch <2.0 mm in diameter by visual
                  estimate that has a clinically significant stenosis at the ostium

               -  TIMI flow 0 (total occlusion) or TIMI flow 1 prior to wire crossing

               -  Excessive tortuosity proximal to or within the lesion

               -  Extreme 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 target vessel

          -  Non-target lesion to be treated during the index procedure meets any of the following
             criteria:

               -  Located within the target vessel

               -  Located within a bypass graft (venous or arterial)

               -  Left main location

               -  Chronic total occlusion

               -  Involves a complex bifurcation (eg, bifurcations requiring treatment with more
                  than 1 stent)

               -  Restenotic from previous intervention

          -  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 target vessel for which
             an intervention within 12 months after the index procedure is likely to be required

          -  Patient has 2 target lesions in the same vessel that are separated by less than 15 mm
             (by visual estimate) Note: Multiple focal stenoses will be considered as a single
             lesion if they can be completely covered with 1 stent.