PE PREMIER CHINA CLINICAL TRIAL

NCT02230254 | Completed Results

• 1 other identifier: S2323
• Study Type: interventional
• Target: 101
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Atherosclerosis

Keywords

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Technical Success Rate

  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

  Participants will be followed for the duration of hospital stay, an expected average of 1 day

Secondary Outcomes (17)

• 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

• 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

• 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

Study Arms (1)

PROMUS POREMIER stent

EXPERIMENTAL

Single-arm treatment group receiving interventional PROMUS PRIMIER study stent

Device: Percutaneous coronary intervention PROMUS PREMIER

Interventions

Percutaneous coronary intervention PROMUS PREMIER DEVICE

PROMUS PREMIER

PROMUS POREMIER stent

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Scientific Corporation: lead

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Results Point of Contact

• Title: Dr. Wang Jian'an
• Organization: Second Affiliated Hospital of Zhejiang University

Yuwei.Zhang@bsci.com

010-85216440

Study Officials

• Jian'an Wang, Doctor

  2nd affiliated hospital of Zhejiang University College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: September 3, 2014
• Study Start: April 9, 2014
• Primary Completion: June 22, 2014
• Study Completion: July 31, 2015
• Last Updated: May 12, 2022
• Results First Posted: May 12, 2022

Record last verified: 2022-02