PE PREMIER CHINA CLINICAL TRIAL

Not Applicable

Completed

Conditions: Atherosclerosis

Interventions: Device: Percutaneous coronary intervention PROMUS PREMIER

Registration Number: NCT02230254

Lead Sponsor: Boston Scientific Corporation

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 lesion(s) ≤34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate)

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 101

Inclusion Criteria

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 Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PROMUS POREMIER stent	Percutaneous coronary intervention PROMUS PREMIER	Single-arm treatment group receiving interventional PROMUS PRIMIER study stent

Primary Outcome Measures

Name	Time	Method
Technical Success Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day	Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of \<30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician

Secondary Outcome Measures

Name	Time	Method
Target Lesion Revascularization (TLR) Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Target Lesion Failure (TLF) Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Target Vessel Revascularization (TVR) Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6month and 12months
Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Cardiac Death Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Non-cardiac Death Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
All Death Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Cardiac Death or MI Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
All Death or MI Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Longitudinal Stent Deformation (LSD) Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Target Vessel Failure (TVF) Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
All Death/MI/TVR Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)	Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Clinical Procedural Success Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
In-stent and In-segment Percent Diameter Stenosis (%DS)	Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
In-stent and In-segment Minimum Lumen Diameter (MLD)	Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Acute Gain	Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months	as measured by angiographic core lab, change from baseline for target lesions