Clinical trial NCT02230254: PE PREMIER CHINA CLINICAL TRIAL
Official title: PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Keywords: Coronary Artery Disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-09-03
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Technical Success Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcomes:
measure: Target Lesion Revascularization (TLR) Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: Target Lesion Failure (TLF) Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: Target Vessel Revascularization (TVR) Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6month and 12months
measure: Target Vessel Failure (TVF) Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: Cardiac Death Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: Non-cardiac Death Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: All Death Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: Cardiac Death or MI Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: All Death or MI Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: All Death/MI/TVR Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: Clinical Procedural Success Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: In-stent and In-segment Percent Diameter Stenosis (%DS)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: In-stent and In-segment Minimum Lumen Diameter (MLD)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: Acute Gain
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: Longitudinal Stent Deformation (LSD) Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Other outcomes:
Locations:
Study officials:
affiliation: 2nd affiliated hospital of Zhejiang University College of Medicine
name: Jian'an Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: