Trial Purpose and Description

A prospective, multicenter, single-arm study designed to assess the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk for bleeding undergoing percutaneous coronary intervention (PCI) with a SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) (EVOLVE Short DAPT Study)

Ages: 18 years and older

Gender: Both

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 therapy,
    • 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 dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin)
  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 trial-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. Subject with treatment of more than 2 lesions during the index procedure
  19. Target lesion(s) treated during the index procedure that involves a side branch ≥ 2.0 mm in diameter by visual estimate
  20. Target lesion(s) treated during the index procedure that involves a clinically significant side branch < 2.0 mm in diameter by visual estimate that has a clinically significant stenosis at the ostium
  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)

Boston Scientific Corporation

Dates: 08/10/2016 - 04/30/2019

Last Updated: 02/22/2018

Study HIC#: 1603017502

Get Involved

For more information about this study, contact:
Nancy J. Hinchion
+1 203-453-7056

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

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