| Eligibility |
Clinical Inclusion Criteria:
1. Subject is = 18 years and = 80 years of age
2. Subject has provided written informed consent as approved by the Independent Ethical
Committee (IEC) or Institutional Review Board (IRB) of the respective clinical site
prior to the study related procedures
3. Subject is eligible for PCI according to the applicable guidelines
4. Subject is an acceptable candidate for coronary artery bypass surgery
5. Subjects with stable or unstable angina pectoris, documented silent ischemia/abnormal
physiologic testing or hemodynamically stable non-ST elevation myocardial infarction
(NSTEMI) patients without angiographic evidence of thrombus at target lesion
Note: STEMI patients may be eligible for the study for treatment of selected
non-culprit lesions, if:
- Subject and target lesion(s) meet all inclusion and no exclusion criteria and
consent occurs at least = 72 hours after successful treatment of the culprit
lesion(s) [lesion(s) causing the acute STEMI];
- Subject is hemodynamically stable with documented declining cardiac biomarkers;
- Target lesion(s) to be treated are not located in the culprit vessel(s) and are
not culprit lesion(s)
6. Subject is eligible for Dual Antiplatelet Therapy (DAPT) with aspirin plus either
clopidogrel, prasugrel, ticagrelor or ticlopidine
7. Documented left ventricular ejection fraction (LVEF) = 30% within 6 months prior to or
during the procedure (prior to randomization)
8. Subject is willing and able to comply with protocol requirements, including completion
of study visits for the duration of the study
Angiographic Inclusion Criteria:
1. Subjects with a maximum of two single de novo target lesions each in separate native
coronary arteries
2. Target vessel must have a reference diameter between 2.5-4.2 mm by visual estimation,
which may be assisted by Quantitative Coronary Angiography (QCA) / Intravascular
Ultrasound (IVUS) / Optical Coherence Tomography (OCT)
3. Target lesion must be =28mm in length by operator visual estimation, which may be
assissted by QCA / IVUS / OCT, (or < 20 mm for target lesion(s) to be treated with a
study device < 3.0 mm in diameter) and should be amenable to treatment with a single
study device
4. Target lesion stenosis = 50% and < 100% by operator visual estimation, which may be
assisted by QCA / IVUS / OCT. Target lesion stenosis < 70% by visual estimation,
should have clinical justification for treatment as per local standards.
5. Target lesion must have a Thrombolysis In Myocardial Infarction (TIMI) flow =1
Clinical Exclusion Criteria:
1. Subject is pregnant and/or breastfeeding or intends to become pregnant during the
duration of the study
2. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with
STEMI < 72 hours prior to the index procedure.
Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study
enrollment.
3. Subject has undergone prior PCI within the target vessel during the last 12 months
prior to the index procedure or prior PCI within a non-target vessel <72 hours prior
to the index procedure if successful and uncomplicated
4. Subject is on dialysis or with impaired renal function (serum creatinine > 2.5 mg/dL
or 221 µmol/L, determined within 72 hours prior to the index procedure)
5. Subject has a known allergy to contrast medium that cannot be adequately premedicated,
or any known allergy to aspirin, P2Y12 inhibitors, both heparin and bivalirudin,
sirolimus, everolimus (or similar limus drugs), poly L-lactide, the scaffold material
(magnesium, aluminium, tantalum), or Xience stent material (cobalt, chromium,
tungsten, nickel, -methacrylic polymer, and fluoropolymer)
6. Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids
are permitted) or has known life-limiting immunosuppressive or autoimmune disease
(e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus
is permitted)
7. Life expectancy less than 1 year
8. Planned surgery or dental surgical procedure within 6 months after index procedure,
unless DAPT can be maintained
9. In the investigator's opinion subject will not be able to comply with the follow-up
requirements
10. Subjects under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT
+ OAC (i.e. triple therapy) can be maintained for a minimum of 1 month
11. Subject has had a stroke or transient ischemic attack (TIA) within 6 months prior to
the index procedure
12. Subject with active bleeding disorder, active coagulopathy, or any other reason, who
is ineligible for DAPT
13. Subject is currently participating or plans to participate in another study with an
investigational device or an investigational drug
Angiographic Exclusion Criteria:
1. Target vessel has been previously treated and the target lesion is within 5 mm
proximal or distal to the previously treated lesion
2. Left main coronary artery disease
3. Target lesion was totally occluded (100% stenosis)
4. Thrombus in target vessel
5. Future planned staged PCI either in target or non-target vessel
6. Ostial target lesion within the left descending (LAD), left circumflex (LCx), or right
coronary artery (within 5.0 mm of vessel origin)
7. Target lesion involves a side branch = 2.0 mm in diameter that requires a two-device
strategy after pre-dilatation
8. Target lesion is located in or supplied by an arterial or venous bypass graft
9. Target lesion with excessive tortuosity proximal to or within the lesion based on
visual estimation or heavily calcified target lesion which cannot be adequately
pre-dilated by a non-compliant and/or cutting/scoring balloon as described in
angiographic exclusion criteria 10.
10. The target lesion requires treatment with the device other than the non-compliant
balloon and/or cutting/scoring balloon prior to scaffold/stent placement (including
but not limited to atherectomy devices, intravascular lithotripsy, drug-coated
balloons etc.)
11. Target vessel was treated with brachytherapy any time prior to the index procedure.
12. Unsuccessful pre-dilatation, defined as residual stenosis > 20% (by visual estimation)
and / or angiographic complications (e.g. distal embolization, side branch closure,
flow-limiting dissections)
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