PROMUS Element Japan Small Vessel Trial
Condition: Atherosclerosis; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atherosclerosis
Intervention: PROMUS Element
Intervention description: PROMUS Element Everolimus-Eluting Coronary Stent System
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Atherosclerosis; Coronary Artery Disease

Summary:

      A non-randomized, small vessel (SV) trial at approximately 15 sites in Japan to enroll 60
      patients with a de novo lesion ≤28 mm in length (by visual estimate) in a native coronary
      artery ≥2.25 mm to <2.50 mm in diameter (by visual estimate). Approximately thirty patients
      will be randomly assigned to the angiographic subset to also undergo angiographic assessment
      after the 12-month clinical follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must be at least 20 years of age

          -  Patient understands the study requirements and the treatment procedures and provides
             written informed consent before any study-specific tests or procedures are performed

          -  Patient is eligible for percutaneous coronary intervention (PCI) with regards to the
             target lesion Patient is considered suitable for PCI if any of the following criteria
             meet.

          -  Evidence of ischemia documented with stress electrocardiogram (ECG) and/or any
             diagnostic imaging tests.

          -  Target vessel supplies blood to relatively large area of the myocardium.

          -  Target lesion is a possible culprit of angina.

          -  Target vessel is a potential collateral source for other major vessels

          -  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 evaluation

        Exclusion Criteria:

          -  Patient has clinical symptoms and/or ECG changes consistent with acute myocardial
             infarction (MI)

          -  Patient has had a known diagnosis of recent MI (i.e., within 72 hours 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 creatine kinase-myoglobin band (CK-MB) is >2× upper limit of normal (ULN), the
                  patient is excluded regardless of the 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 the time of the index procedure.

               -  Troponin >1× ULN with at least one of the following.

               -  Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia
                  (e.g., >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 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 (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 (e.g., heparin,
             warfarin) for indications other than acute coronary syndrome

          -  Patient has a platelet count <100,000 cells/mm^3 or >700,000 cells/mm^3

          -  Patient has a white blood cell (WBC) count <3,000 cells/mm^3

          -  Patient has documented or suspected liver disease, including laboratory evidence of
             hepatitis

          -  Patient is on dialysis or has known renal insufficiency (i.e., Creatinine > 2.0 mg/dl
             or >150 μmol/L)

          -  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 PCI (e.g., balloon
             angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index
             procedure (excluding PCI of the non-target lesion within the target vessel treated
             during the index procedure (Refer to Multiple Interventions During 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 or side branch 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

          -  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, chromium, nickel, tungsten, acrylic,
             fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be
             adequately premedicated

          -  Patient has an active peptic ulcer or active gastrointestinal (GI) bleeding

          -  Patient has one of the following.

               -  Other serious medical illness (e.g., cancer, congestive heart failure) that may
                  reduce life expectancy to 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

          -  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

          -  Patient 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.)

          -  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 1 target lesion and 1 non-target lesion, which will be treated
             during the index procedure