SHS_300306 WESJ CBOS 15284

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 the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System

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.

Select Inclusion Criteria:

Considered at high risk for bleeding.
At least 18 years of age
Implantation of at least one SYNERGY stent within the preceding 3 calendar days
Must be able to take study required antiplatelet therapy (as required per protocol)
Willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at the 3-month milestone, if eligible per protocol

Select Exclusion Criteria:

Indication for the index procedure of acute ST elevation MI (STEMI) or for the index procedure of Non ST elevation MI (NSTEMI), based on the 3rd Universal MI definition
Treatment with another coronary stent, other than SYNERGY, during the index procedure
Planned staged procedures. (Note: Planned staged procedures are allowed if performed within 7 days and with only SYNERGY stents).
Known allergy to contrast (that cannot be adequately pre-medicated), the SYNERGY stent system or protocol-required concomitant medications
Implantation of a drug-eluting stent within 9 months prior to index procedure
Previously treated at any time with intravascular brachytherapy
Active peptic ulcer or active gastrointestinal (GI) bleeding
Participating in an investigational drug or device clinical trial that has not reached its primary endpoint
Intends to participate in an investigational drug or device clinical trial within 15 months following the index procedure
Judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use
Planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure
Current medical condition with a life expectancy of less than 15 months
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
Unprotected left main coronary artery disease ( > 50% diameter stenosis)
Planned treatment of more than 3 lesion
Planned treatment of lesions in more than 2 major epicardial vessels
Target lesion(s) treated that involve complex bifurcation (i.e. bifurcation lesion requiring treatment with more than one stent)
Target lesion(s) is restenotic from a previous stent implantation
Target lesion(s) is located within a saphenous vein graft or an arterial graft
Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
Thrombus, or possible thrombus, present in the target vessel (by visual estimate)
Phase IV
NCT02605447
Heart and Vascular, All Other
Coronary Artery Disease
R. Jeffery Westcott, M.D.
Boston Biomedical
Jeremy Gillis
  • Swedish Medical Center