Status:
COMPLETED
PE PREMIER CHINA CLINICAL TRIAL
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Atherosclerosis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)
Detailed Description
To evaluate clinical and peri-procedural angiographic outcomes for the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System in the treatment of subjects with atherosclerotic les...
Eligibility Criteria
Inclusion
- Clinical Inclusion (CI) Criteria
- CI1. Subject must be at least 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
- Angiographic Inclusion (AI) Criteria (visual estimate)
- AI1. Target lesion(s) must be 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 ( Target lesion(s) length must be ≤28 mm for reference vessel diameter (RVD) = 2.25 mm Target lesion(s)) (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 test or imaging stress test, or elevated biomarkers) prior to 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 pre-dilated/pretreated Note: Successful pre-dilatation/pretreatment refers to dilatation with a balloon catheter of appropriate length and diameter, or pretreatment with/or rotational coronary atherectomy, or cutting/scoring balloon with no greater than 50% residual stenosis and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C.
Exclusion
- Clinical Exclusion (CE) Criteria
- CE1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with Acute MI (include STEMI and Non- STEMI ) within 1 week
- CE2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
- CE3. Subject has received an organ transplant or is on a waiting list for an organ transplant
- CE4. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
- CE5. Planned PCI (including staged procedures) or CABG after the index procedure
- CE6. Subject previously treated at any time with intravascular brachytherapy
- CE7. Subject has a known allergy to contrast (that cannot be adequately pre-medicated) and/or 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)
- CE8. Subject has one of the following (as assessed prior to the index procedure):
- Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 12 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
- Angiographic Exclusion (AE) Criteria (visual estimate)
- AE1. Planned treatment of more than 3 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
- AE4. Subject has 2 target lesions in the same vessel that are separated by less than 20 mm (by visual estimate)
- AE5. Target lesion(s) is located in the left main
- AE6. 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.
- AE7. Target lesion(s) is located within a saphenous vein graft or an arterial graft
- AE8. Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
- AE9. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
- AE10. Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
- AE11. Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent
- AE12. Subject has unprotected left main coronary artery disease (\>50% diameter stenosis)
- AE13. Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure
- AE14. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)
- AE15. Excessive tortuosity proximal to or within the lesion
- AE16. Excessive angulation proximal to or within the lesion
- AE17. Target lesion and/or the target vessel proximal to the target lesion is moderately to severely calcified by visual estimate
- AE18. 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
Key Trial Info
Start Date :
April 9 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2015
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT02230254
Start Date
April 9 2014
End Date
July 31 2015
Last Update
May 12 2022
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