EVOLVE II QCA: A Prospective, Multicenter Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)
Condition: Atherosclerotic Lesion(s)
Intervention: SYNERGY
Intervention description: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug-eluting stents

Summary:

      The purpose of this study is to evaluate 9 month angiographic and intravascular ultrasound
      (IVUS) data for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
      (SYNERGY 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).
    

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 <100% with
             thrombolysis in Myocardial Infarction (TIMI) flow >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 pre-dilated/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 (clopidogrel,
             ticlopidine, prasugrel, or ticagrelor), 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 <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 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., New York Heart Association (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)