SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance to Examine the Safety of Cessation of Dual Anti-Platelet Therapy in High Bleeding Risk Patients at One Month

DAPT or Dual Antiplatelet Therapy is a combination of two medications given after a
percutaneous coronary intervention (PCI) with a drug eluting stent. DAPT is used to help make
the platelets in your blood slick so they don't clump or stick together. If the platelets
stick together and form a blood clot in the stent it is called a stent thrombosis and will
cause an immediate heart attack or MI.

The medications used for DAPT are low dose Aspirin (81mg) and one of three (3) antiplatelet
medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) . The
standard length of time to take DAPT after a stent placement is 6 months to 1 year. Dapt is
associated with an increased risk of bleeding. Because you are considered to be at a high
risk for bleeding due to one or a combination of reasons this study is trying to determine if
a shorter use of DAPT in combination with the Synergy® stent and an imaging tool called IVUS
used during your PCI procedure is safe and effective to reduce the potential for serious
bleeding events and early stent thrombosis.

The Synergy® stent was chosen because of its enhanced method of healing and reduced
inflammation of the artery after placement. Because of this the Synergy stent may be a better
choice for patients who are at high risk for bleeding and could benefit from a shortened
period of DAPT.

Intravascular ultrasound or IVUS provides a visual image of the inside of the coronary
artery. It is used in patients undergoing PCI or stent placement for a few reasons; prior to
placing the stent it is used to measure the artery's width to select the proper size diameter
of a stent, also the length of the blockage to select the appropriate length of the stent and
to visualize the amount of narrowing or blockage. After the stent is placed IVUS is used to
make sure the stent itself is fully expanded and sits up against the wall of the artery. This
is called apposition. If stents are not fully expanded and sit up against the wall of the
artery early reblockage may occur. In short the IVUS aids in the ideal placement of the
stent.

By using the combination of the Synergy® Stent with the IVUS the expectation is to safely
decrease the length of time you take DAPT from 6-12 months to 1 month. With the benefit of
decreasing the risk of bleeding events.

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 bleeding
associated with >1 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

- In the opinion of investigator, patient is at significant risk of falling

- Patient abuses drugs or alcohol 2. Subject must be 18 years of age 3. Subject must
have had implantation of at least one SYNERGY Stent®s and the use of Boston Scientific
IVUS 4. Subject must be able to take study required dual antiplatelet therapy (1 month
of P2Y12 inhibitor and aspirin, 13 months of antiplatelet monotherapy) 5. Subject is
willing to comply with all protocol requirements, including agreement to stop taking
P2Y12 inhibitor at the 1-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.
Patients must meet the following IVUS success criteria:

1. treated lesions in which the stent cross sectional area exceeds the distal
reference cross sectional area

2. Otherwise additional post-dilatation should be performed, followed by repeat
IVUS.

Exclusion Criteria:

1. Subject with an indication for the index procedure of acute ST elevation MI (STEMI)

2. Index procedure Saphenous vein graft lesion treatment

3. TIMI flow 0 (total occlusion)

4. With the exception of peri-procedural Non Q-wave MI, a Subject that has a clinical
event (Cardiac Death, MI, ARC Def/Prob ST, repeat PCI or CABG) within 30 days of index
procedure will not be eligible for DAPT cessation, but will be followed in the trial,
yet not included in the primary endpoint analysis. They will be included in a
secondary endpoint analysis

5. Subject with treatment with another coronary stent, other than SYNERGY Stent®s, during
the index procedure

6. Subject who did not receive Boston Scientific IVUS guided stent implantation and
assessment

7. Patients undergoing planned staged procedures are excluded if performed >7 days
following the index procedure. Staged procedures within 7 days of the index procedure
are permitted only if SYNERGY stents are used. Discontinuation of DAPT should occur 1
month after the last PCI procedure is completedSubject with planned staged procedures.
Note: Patients undergoing planned staged procedures are excluded if performed > 7 days
following the index procedure or if SYNERGY stents are not used)

8. Subject has a known allergy to: contrast (that cannot be adequately pre-medicated),
the SYNERGY Stent®s system or protocol-required concomitant medications (e.g.,
everolimus or structurally related compounds, polymer or individual components, all
P2Y12 inhibitors and aspirin)

9. Subject previously treated at any time with intravascular brachytherapy

10. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding

11. 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)

12. Subject intends to participate in an investigational drug or device clinical trial
within 12 months following the index procedure (Note: registry, observational, data
collection studies are not exclusionary)

13. Subject is judged inappropriate for discontinuation from P2Y12 inhibitor use at 1
month, due to another condition requiring chronic P2Y12 inhibitor use

14. Subject with planned surgery or procedure necessitating discontinuation of P2Y12
inhibitor within 1 month following index procedure

15. Subject is a woman who is pregnant or nursing

16. Subject with a current medical condition with a life expectancy of less than 12 months

17. Subject with Non ST elevation MI (NSTEMI) at the time of the index procedure , based
on the 3rd Universal MI definition

18. Subject with implantation of a drug-eluting stent other than SYNERGY Stent®s within 11
months prior to index procedure

19. Target lesion(s) is located in the left main

20. Potential Target lesion(s) that involve a complex bifurcation (i.e. bifurcation lesion
requiring treatment with more than one stent)

21. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)

22. Have been previously consented for this trial and screen failed

23. Patients requiring a treatment of more than two native epicardial vessels with a
maximum of two lesions per vessel. Each treated lesion requires Boston Scientific IVUS
guided stenting.

24. Patients who do not meet the following IVUS success criteria:

1. treated lesions in which the stent cross sectional area exceeds the distal
reference cross sectional area

2. Otherwise additional post-dilatation should be performed, followed by repeat
IVUS.

25. Treatment of non-target lesions