| Eligibility |
Inclusion Criteria:
- CI1. Subject must be 18 -75 years of age
- CI2. Subject (or legal guardian) understands the trial requirements and the treatment
procedures and provides written informed consent before any trial-specific tests or
procedures are performed
- CI3. Subject is eligible for percutaneous coronary intervention (PCI)
- CI4. Subject has symptomatic coronary artery disease with objective evidence of
ischemia or silent ischemia
- CI5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
- CI6. Subject is willing to comply with all protocol-required follow-up evaluation
- CI7. Subject has a left ventricular ejection fraction (LVEF) >30% as measured within
60 days prior to enrollment
- AI1. Target lesion(s) must be de novo lesion located in a native coronary artery with
a visually estimated reference vessel diameter (RVD) =2.25 mm and =4.0 mm
- AI2. Target lesion(s) length must be =34 mm (by visual estimate)
- AI3. Target lesion(s) must have visually estimated stenosis =50% and <100% with
thrombolysis in Myocardial Infarction (TIMI) flow >1 and one of the following:
stenosis =70%, abnormal fractional flow reserve (FFR), abnormal stress or imaging
stress test, or elevated biomarkers prior to the procedure
- AI4. Coronary anatomy is likely to allow delivery of a study device to the target
lesions(s)
- AI5. The first lesion treated must be successfully predilated/pretreated
Exclusion Criteria:
- CE1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent
with acute MI .
- CE2. Subject with unstable angina or recent MI (within 1 week) must have CK/CK-MB or
troponin documented prior to the procedure and are excluded if any of the following
criteria are met at the time of the index procedure:
- If CK MB >2× upper limit of normal (ULN), the subject is excluded regardless of
the CK Total.
- If CK Total >2× ULN, either CK-MB or troponin must be drawn and the subject is
excluded if either CK-MB or troponin is abnormal.
- If neither CK Total or CK MB is drawn but troponin is, the subject is excluded if
troponin >1× ULN and the subject has at least one of the following:
- Subject has ischemic symptoms and ECG changes indicative of ongoing ischemia
(e.g., >1 mm ST segment elevation or depression in consecutive leads or new
left bundle branch block [LBBB])
- Development of pathological Q waves in the ECG or
- Imaging evidence of new loss of viable myocardium or new regional wall
motion abnormality
- CE3. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or
mechanical circulatory support, or intractable ventricular arrhythmias or ongoing
intractable angina
- CE4. Subject has received an organ transplant or is on a waiting list for an organ
transplant
- CE5. Subject is receiving or scheduled to receive chemotherapy within 30 days before
or after the index procedure
- CE6. Planned PCI or CABG after the index procedure
- CE7. Subject has a known allergy to the trial stent system or protocol-required
concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel,
everolimus or structurally related compounds, polymer or individual components,
clopidogrel, or aspirin) and contrast (that cannot be adequately premedicated)
- CE8. Subject has a known condition(s) of the following (as assessed from the time of
screening through the day of index procedure):
- Other serious medical illness (e.g., cancer, congestive heart failure) that may
reduce life expectancy to less than 24 months
- Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
- Planned procedure that may cause non-compliance with the protocol or confound
data interpretation
- CE9. Subject is receiving chronic (=72 hours) anticoagulation therapy (i.e., heparin,
Coumadin) for indications other than acute coronary syndrome
- CE10. Subject with out of range complete blood count (CBC) values that are determined
by the study physician to be clinically significant.
- CE11. Subject has documented or suspected liver disease, including laboratory evidence
of hepatitis
- CE12. Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL
(177µmol/L)
- CE13. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood
transfusions
- CE14. Subject has had a history of cerebrovascular accident (CVA) or transient
ischemic attack (TIA) within the past 6 months
- CE15. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
- CE16. Subject has signs or symptoms of active heart failure (i.e., NYHA class IV) at
the time of the index procedure
- CE17. Subject is participating in another investigational drug or device clinical
trial that has not reached its primary endpoint
- CE18. Subject intends to participate in another investigational drug or device
clinical trial within 12 months after the index procedure
- CE19. Subject with known intention to procreate within 12 months after the index
procedure (women of child-bearing potential who are sexually active must agree to use
a reliable method of contraception from the time of screening through 12 months after
the index procedure)
- CE20. Subject is a woman who is pregnant or nursing (a pregnancy test must be
performed within 7 days prior to the index procedure in women of child-bearing
potential)
- CE21. Target vessel has been treated with any type of PCI (e.g., balloon angioplasty,
stent, cutting balloon, atherectomy) within 12 months prior to the index procedure
- AE1. Planned treatment of more than 2 lesions
- AE2. Planned treatment of lesions in more than 2 major epicardial vessels
- AE3. Planned treatment of a single lesion with more than 1 stent Note: Planned use of
2 overlapping stents will be allowed in subjects randomized to PROMUS Element Plus
where lesion length is =28 mm and 2.25 mm stents are used.
- AE4. Target lesion meets any of the following criteria:
- Left main location
- Located within 3 mm of the origin of the left anterior descending (LAD) coronary
artery or left circumflex (LCX) coronary artery by visual estimate
- Located within a saphenous vein graft or an arterial graft
- Will be accessed via a saphenous vein graft or an arterial graft
- TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
- Thrombus, or possible thrombus, present in the target vessel
- Excessive tortuosity proximal to or within the lesion
- Excessive angulation proximal to or within the lesion
- Target lesion and/or the target vessel proximal to the target lesion is
moderately to severely calcified by visual estimate
- Involves a side branch =2.0 mm in diameter by visual estimate or a side branch
<2.0 mm in diameter by visual estimate which requires treatment
- AE5. Target lesion(s) treated during the index procedure that involves a complex
bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
- AE6. Target lesion(s) is restenostic from a previous stent implantation or study stent
would overlap with a previous stent
- AE7. Subject has unprotected left main coronary artery disease (>50% diameter
stenosis)
- AE8. Subject has protected left main coronary artery disease (>50% diameter stenosis
in the LMCA with bypass graft(s) to the left coronary artery) and a target lesion in
the LAD or LCX
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