EVOLVE Short DAPT Study

Inclusion Criteria

• 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
• Subject must be at least 18 years of age
• Subject must have had implantation of at least one SYNERGY stent within the preceding 3 calendar days
• Subject must be able to take study required antiplatelet therapy (as required per protocol)
• 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
• Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any study-specific procedures are performed
• 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

• Subject with an indication for the index procedure of acute ST elevation MI (STEMI)
• Subject with an indication for the index procedure of Non ST elevation MI (NSTEMI), based on the 3rd Universal MI definition
• Subject with treatment with another coronary stent, other than SYNERGY, during the index procedure
• Subject with planned staged procedures. (Note: Planned staged procedures are allowed if performed within 7 days and with only SYNERGY stents).
• 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)
• Subject with implantation of a drug-eluting stent within 9 months prior to index procedure
• Subject previously treated at any time with intravascular brachytherapy
• Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
• 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)
• 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)
• Subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use
• Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure
• Subject is a woman who is pregnant or nursing
• Subject with a 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
• Subject has 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 saphenou