A Clinical Trial to Assess the SYNERGY 48 mm Stent System for the Treatment of Atherosclerotic Lesion(s)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: SYNERGY 48 mm
Intervention description: A drug eluting coronary stent system
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Prospective, open label, single arm, multi-center
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug-Eluting Stents

Summary:

      EVOLVE 48 is a prospective, open label, single arm, multi-center trial. The purpose of this
      study is to assess the FDA requirement for safety and effectiveness of the SYNERGY 48 mm
      Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) > 34 mm
      and ≤ 44 mm in length (by visual estimate) in native coronary arteries ≥2.5 mm to ≤4.0 mm in
      diameter (by visual estimate).
    

Eligibility criteria:

        Clinical 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

          -  Subject is eligible for percutaneous coronary intervention (PCI) and is an acceptable
             candidate for coronary artery bypass grafting (CABG)

          -  Subject has either:

               -  Symptomatic coronary artery disease with one of the following: stenosis ≥ 70%,
                  abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test,
                  or elevated biomarkers prior to the procedure

               -  OR

               -  Documented silent ischemia based on one of the following: abnormal fractional
                  flow reserve (FFR), abnormal stress or imaging stress test, or elevated
                  biomarkers prior to the procedure

          -  Subject is willing to comply with all protocol-required follow-up evaluation
             Angiographic Inclusion Criteria (visual estimate)

          -  Target lesion must be located in a native coronary artery with a visually estimated
             reference vessel diameter (RVD) ≥2.5 mm and ≤4.0 mm

          -  Target lesion length must be >34 mm and ≤44 mm (by visual estimate)

          -  Target lesion must have visually estimated stenosis ≥50% and <100% with thrombolysis
             in Myocardial Infarction (TIMI) flow >1

          -  Coronary anatomy is likely to allow delivery of a study device to the target lesion

          -  The target lesion must be successfully predilated/pretreated. If a non-target lesion
             is treated, it should be treated first and should be deemed an angiographic success
             Note: Angiographic success is a mean lesion diameter stenosis < 50% (< 30% for stents)
             in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the
             physician, without the occurrence of prolonged chest pain or ECG changes consistent
             with MI.

        Note: Successful predilatation/pretreatment refers to dilatation with a balloon catheter of
        appropriate length and diameter, or pretreatment with directional or rotational coronary
        atherectomy, laser or cutting/scoring balloon with no greater than 50% residual stenosis
        and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C.

        Clinical 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, or aspirin)

          -  Subject has one of the following (as assessed prior to enrollment):

               -  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 signs or symptoms of active heart failure (i.e., New York Heart
             Association (NYHA) class IV) at the time of the index procedure

          -  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 Angiographic Exclusion Criteria (visual
             estimate)

          -  Subject has more than 1 target lesion, or more than 1 target lesion and 1 non-target
             lesion, which will be treated during the index procedure Note: Multiple focal stenoses
             will be considered as a single lesion if they can be completely covered with 1 study
             stent

          -  Treatment of lesions in more than 2 major epicardial vessels Note: 1 target lesion in
             the target vessel and 1 non-target lesion in non-target vessel is allowed

          -  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)

          -  Target lesion meets any of the following criteria:

          -  Treatment of a single lesion with more than 1 stent

          -  Left main location

          -  Lesion 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

          -  Lesion is located within a saphenous vein graft or an arterial graft

          -  Lesion will be accessed via a saphenous vein graft or arterial graft

          -  Lesion with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire
             crossing

          -  Lesion treated during the index procedure that involves a complex bifurcation (e.g.,
             bifurcation lesion requiring treatment with more than 1 stent)

          -  Lesion is restenotic from a previous stent implantation or study stent would overlap
             with a previous stent

          -  Non-target lesion meets any of the following criteria:

          -  Located within the target vessel

          -  Left main location

          -  Lesion is located within a saphenous vein graft or an arterial graft

          -  Lesion with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire
             crossing

          -  Lesion treated during the index procedure that involves a complex bifurcation (e.g.,
             bifurcation lesion requiring treatment with more than 1 stent)

          -  Requires additional unplanned stents (treatment of the non-target lesion with more
             than one stent is permitted as long as the stents are initially planned)

          -  Treatment not deemed an angiographic success Note: Angiographic success is a mean
             lesion diameter stenosis < 50% (< 30% for stents) in 2 near-orthogonal projections
             with TIMI 3 flow, as visually assessed by the physician, without the occurrence of
             prolonged chest pain or ECG changes consistent with MI.