OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI

1. Subject must be at least 18 years of age.
2. Subject must have evidence of myocardial ischemia (e.g., stable angina,
silent ischemia, unstable angina, or acute myocardial infarction) suitable for
elective PCI.
3. Patients undergoing planned XIENCE stent implantation during a clinically
indicated PCI procedure meeting one or more of the following criteria:
A) High clinical-risk, defined as;
i. Medication-treated diabetes mellitus, AND/OR
B) High angiographic-risk lesion(s), with at least one target lesion in each
target vessel planned for randomization meeting at least one of the following
criteria;
i. Target lesion is the culprit lesion responsible for either:
• NSTEMI, defined as a clinical syndrome consistent with an acute coronary
syndrome and a minimum troponin of 1 ng/dL (may or may not have returned to
normal), and >1 mm ST segment deviation and/or dynamic T wave changes at rest
within 7 days, OR
• STEMI >24 hours from the onset of ischemic symptoms
ii. long or multiple lesions (defined as intended total stent length in any
single target vessel >=28 mm),
iii. bifurcation intended to be treated with 2 planned stents (i.e. in both the
main branch and side branch), and where the planned side branch stent is >= 2.5
mm in diameter.
iv. angiographic severe calcification (defined as angiographically visible
calcification on both sides of the vessel wall in the absence of cardiac
motion),
v. chronic total occlusion (CTO) (enrolment and randomization in this case
performed only after successful antegrade wire escalation crossing and
pre-dilatation)
vi. in-stent restenosis (all patterns, as long as the lesion is at or within
the stent margin(s) and has an angiographically visually-assessed DS >=70% or DS
>=50% with non-invasive or invasive evidence of ischemia)
4. All target lesions (those lesions to be randomized) must have a visually
estimated or quantitatively assessed %DS of either >=70%, or >=50% plus one or
more of the following: an abnormal functional test (e.g. fractional flow
reserve, stress test) signifying ischemia in the distribution of the target
lesion(s) or biomarker positive ACS with plaque disruption or thrombus.
5. All target lesions must be planned for treatment with only >=2.5 mm and <=3.5
mm stents and post-dilatation balloons based on pre-PCI angiographic visual
estimation. The only exception is for long target lesions (visually estimated
as >20 mm), in which after implantation of a <=3.5 mm stent up to half of the
stented segment may be post-dilated with balloons >3.5 mm as needed per
operator judgment.
6. No more than 2 target lesions requiring PCI are present in any single
vessel., and no more than 2 target vessels are allowed. Thus, up to 4
randomized target lesions per patient in a maximum of 2 target vessels are
allowed, including branches. The intended target lesions will be declared just
prior to randomization.
7. All target lesions intended to be treated by PCI in the target vessel are
amenable to OCT-guided PCI.
8. For a female subject of childbearing potential, a pregnancy test must be
performed with negative results known within 7 days prior to the index
procedure per site standard, and pregnancy must not be intended for at least 2
years.
9. For a female subject with a recent birth, subject is not breast-feeding at
the time of the screening visit and will not be breast-feeding for up to 2
years following the index procedure.
10. Subject or a legally authorized representative must provide written
Informed Consent prior to any study related procedure.

Clinical Criteria for exclusion:
1. STEMI <=24 hours from the onset of ischemic symptoms.
2. Creatinine clearance <=30 ml/min/1.73 m2 (as calculated by MDRD formula for
estimated GFR)5 and not on dialysis. Note: chronic dialysis dependent patients
are eligible for enrolment regardless of creatinine clearance.
3. Hypotension, shock or need for mechanical support or intravenous vasopressors
4. CHF (Killip class >=2 or NYHA class >=3)
5. LVEF <=30% by the most recent imaging test within 30 days prior to procedure
(echo, MRI, contrast left ventriculography or other)
6. Unstable ventricular arrhythmias
7. Inability to take DAPT (both aspirin and a P2Y12 inhibitor) for at least 12
months in the patient presenting with an ACS, or at least 6 months in the
patient presenting with stable CAD, unless the patient is also taking chronic
oral anticoagulation in which case a shorter duration of DAPT may be prescribed
per local standard of care.
8. Planned cardiac or non-cardiac surgery within 24 months after the index
procedure
9. Prior PCI within the target vessel within 12 months (unless the target
lesion is the prior PCI site - i.e. in-stent restenosis)
10. Any planned PCI within the target vessel(s) within 24 months after the
study procedure, other than a planned staged intervention in a second
randomized target vessel.
11. Any prior PCI in a non-target vessel within 24 hours before the study
procedure, or within previous 30 days if unsuccessful or complicated.
12. Subject has known hypersensitivity or contraindication to any of the study
drugs (including heparin and all P2Y12 inhibitors, one or more components of
the study devices, including everolimus, cobalt, chromium, nickel, platinum,
tungsten, acrylic and fluoropolymers, or radiocontrast dye that cannot be
adequately pre-medicated.
13. Subject has received any solid organ transplants or is on a waiting list
for any solid organ transplants.
14. Subject is receiving immunosuppressant therapy or has known
immunosuppressive or severe autoimmune disease that requires chronic
immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus
erythematosus, etc.). Note: corticosteroids are not included as
immunosuppressant therapy.
15. Subject has previously received or is scheduled to receive radiotherapy to
a coronary artery (vascular brachytherapy), or the chest/mediastinum.
16. Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
17. Subject has a documented or suspected hepatic disorder as defined as
cirrhosis or Child-Pugh >= Class B.
18. Subject has a history of bleeding diathesis or coagulopathy, or has had a
significant gastro-intestinal or significant urinary bleed within the past six
months.
19. Subject has had a cerebrovascular accident or transient ischemic
neurological attack (TIA) within the past six months, or any prior intracranial
bleed, or any permanent neurologic defect, or any known intracranial pathology
(e.g., aneurysm, arteriovenous malformation, etc.).
20. Subject has extensive peripheral vascular disease that precludes safe 6
French sheath insertion. Note: femoral arterial disease does not exclude the
patient if radial access may be used.
21. Subject has life expectancy <2 years for any non-cardiac cause.
22. Subject is in the opinion of the Investigator or designee unable to comply
with the requirements of the study protocol or is unsuitable for the study for
any reason.
23. Subject is currently participating in another investigational drug or
device clinical study that has not yet completed its primary endpoint6.
24. Subject is part of a vulnerable population who, in the judgment of the
investigator, is unable to give Informed Consent for reasons of incapacity,
immaturity, adverse personal circumstances or lack of autonomy. This may
include: Individuals with mental disability, persons in nursing homes,
children, impoverished persons, persons in emergency situations, homeless
persons, nomads, refugees, and those incapable of giving informed consent.
Vulnerable populations also may include members of a group with a hierarchical
structure such as university students, subordinate hospital and laboratory
personnel, employees of the Sponsor, members of the armed forces, and persons
kept in detention.Angiographic exclusion criteria:
A) Syntax score >=33, unless a formal meeting of the Heart Team, including a
cardiac surgeon, concludes that PCI is appropriate.
B) Planned use of any stent <2.5 mm in a randomized vessel based on visual
estimation (note: a smaller stent may be used in a bail-out scenario - e.g. to
treat a distal dissection - but its use cannot be planned prior to enrolment)
C) Planned use of a stent or post-dilatation balloon >=3.75 mm for the
randomized target lesion (see inclusion criteria #2 for the one exception to
this exclusion criterion)
D) Severe vessel tortuosity or calcification in a randomized target vessel such
that it is unlikely that the OCT catheter can be delivered (note: severe vessel
calcification is allowed if it is expected that the OCT catheter can be
delivered at baseline or after vessel preparation with balloon pre-dilatation
or atherectomy)
E) The randomized target lesion is in the left main coronary artery
F) The randomized target lesion is in a bypass graft conduit. Note: A native
coronary artery may be randomized if a prior bypass graft conduit to the vessel
is totally occluded, but not if it is patent.
G) The randomized target lesion is an ostial RCA stenosis
H) The randomized target lesion is a stent thrombosis
I) Planned use of any stent other than Xience in a randomized target
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