EVOLVE Short DAPT Study
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: 3 months of dual antiplatelet therapy (DAPT); SYNERGY Stent System
Intervention description: 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin; SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2009.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The EVOLVE Short DAPT Study is a prospective, multicenter, single-arm study designed to
      assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with a
      SYNERGY Stent System.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is considered at high risk for bleeding, defined as meeting one or more of the
             following criteria at the time of enrollment:

               -  ≥ 75 years of age and, in the opinion of the investigator, the risk of major
                  bleeding associated with >3 months of DAPT outweighs the benefit,

               -  need for chronic or lifelong anticoagulation,

               -  history of major bleeding (severe/life threatening or moderate bleeding based on
                  the GUSTO classification) within 12 months of the index procedure,

               -  history of stroke (ischemic or hemorrhagic),

               -  renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent),

               -  platelet count ≤100,000/μL

          2. Subject must be at least 18 years of age

          3. Subject must have had implantation of at least one SYNERGY stent within the preceding
             3 calendar days

          4. Subject must be able to take study required antiplatelet therapy (as required per
             protocol)

          5. Subject is willing to comply with all protocol requirements, including agreement to
             stop taking P2Y12 inhibitor at the 3-month milestone, if eligible per protocol

          6. Subject (or legal guardian) understands the trial requirements and the treatment
             procedures and provides written informed consent before any study-specific procedures
             are performed

          7. For subjects less than 20 years of age enrolled at a Japanese site, the subject/ the
             subject's legal representative must provide written informed consent before any
             study-specific tests or procedures are performed

        Exclusion Criteria:

          1. Subject with an indication for the index procedure of acute ST elevation MI (STEMI)

          2. Subject with an indication for the index procedure of Non ST elevation MI (NSTEMI),
             based on the 3rd Universal MI definition

          3. Subject with treatment with another coronary stent, other than SYNERGY, during the
             index procedure

          4. Subject with planned staged procedures. (Note: Planned staged procedures are allowed
             if performed within 7 days and with only SYNERGY stents).

          5. Subject has a known allergy to contrast (that cannot be adequately pre-medicated), the
             SYNERGY stent system or protocol-required concomitant medications (e.g., everolimus or
             structurally related compounds, polymer or individual components, all P2Y12 inhibitors
             and aspirin)

          6. Subject with implantation of a drug-eluting stent within 9 months prior to index
             procedure

          7. Subject previously treated at any time with intravascular brachytherapy

          8. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding

          9. Subject is participating in an investigational drug or device clinical trial that has
             not reached its primary endpoint (Note: registry, observational, data collection
             studies are not exclusionary)

         10. Subject intends to participate in an investigational drug or device clinical trial
             within 15 months following the index procedure (Note: registry, observational, data
             collection studies are not exclusionary)

         11. Subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months,
             due to another condition requiring chronic P2Y12 inhibitor use

         12. Subject with planned surgery or procedure necessitating discontinuation of P2Y12
             inhibitor within 3 months following index procedure

         13. Subject is a woman who is pregnant or nursing

         14. Subject with a current medical condition with a life expectancy of less than 15 months

         15. Target lesion(s) is located in the left main

         16. 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

         17. Subject has unprotected left main coronary artery disease ( > 50% diameter stenosis)

         18. Planned treatment of more than 3 lesion

         19. Planned treatment of lesions in more than 2 major epicardial vessels

         20. Target lesion(s) treated that involve complex bifurcation (i.e. bifurcation lesion
             requiring treatment with more than one stent)

         21. Target lesion(s) is restenotic from a previous stent implantation

         22. Target lesion(s) is located within a saphenous vein graft or an arterial graft

         23. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide
             wire crossing

         24. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)