Prospective, Randomized, Multicenter Trial to Assess PROMUS™ Element™ Stent
PTChina
PLATINUM China: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS™ Element™) for the Treatment of a Single De Novo Coronary Artery Lesion
1 other identifier
interventional
500
1 country
15
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System for the treatment of subjects in China with a single de novo atherosclerotic coronary artery lesion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2011
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 25, 2011
CompletedFirst Posted
Study publicly available on registry
January 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
November 20, 2024
CompletedMarch 11, 2025
March 1, 2025
2.2 years
January 25, 2011
November 6, 2014
March 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
9 Month In-stent Late Loss
The primary endpoint is in-stent late loss measured by quantitative coronary angiography (QCA) at 9 months post-index procedure.
9 Months
Secondary Outcomes (15)
Target Vessel Failure (TVF) Rate
In hospital and at 2 years
Target Lesion Revascularization (TLR) Rate
In hospital and at 2 years
Target Vessel Revascularization (TVR) Rate
In hospital and at 2 years
Target Lesion Failure (TLF) Rate
In hospital and at 2 years
Major Adverse Cardiac Event (MACE) Rate
In hospital and at 2 years
- +10 more secondary outcomes
Study Arms (2)
PROMUS Element
EXPERIMENTALPROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
TAXUS Liberté DES
ACTIVE COMPARATORTAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
Interventions
Everolimus-eluting Coronary Stent Drug-eluting Stent (DES) implantation
Paclitaxel-eluting Coronary Stent Drug-eluting Stent (DES) implantation
Eligibility Criteria
You may qualify if:
- Subject must be age 18 - 75 years
- 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
- Subject is eligible for percutaneous coronary intervention (PCI)
- Subject has symptomatic coronary artery disease or documented silent ischemia
- Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
- Subject has a left ventricular ejection fraction (LVEF) ≥30% as measured within 60 days prior to enrollment
- Subject is willing to comply with all protocol-required follow-up evaluations
- Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.50 mm and ≤ 4.00 mm.
- Target lesion length must measure \<38 mm (by visual estimate)
- Target lesion must have visually estimated stenosis ≥50% and \<100% with Thrombolysis in Myocardial Infarction (TIMI) flow \>1.
- Target lesion must be successfully pre-dilated.
You may not qualify if:
- Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI
- Subject with unstable angina or recent MI (within 1 week) must have creatine kinase (CK)/ creatine kinase-myoglobin band(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:
- of 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 stent thrombosis (ST) segment elevation or depression in consecutive leads or new left bundle branch block (LBBB)
- Development of pathological Q waves in the ECG or;
- Subject has received an organ transplant or is on a waiting list for an organ transplant
- Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
- Subject is receiving oral or intravenous immunosuppressive therapy (Note: use of inhaled steroids does not exclude subjects) or has known life- limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; Note: this does not include diabetes mellitus)
- Subject is receiving chronic (≥72 hours) anticoagulation therapy (e.g., heparin, coumadin) for indications other than acute coronary syndrome
- Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
- Subject has a white blood cell (WBC) count \<3,000 cells/mm3
- Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
- Subject is on dialysis or has serum creatinine level \>2.0 mg/dL
- +33 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Cardiovascular Institute and Fu Wai Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University First Hospital
Beijing, China
The Chinese People's Liberation Army General Hospital
Beijing, China
Huaxi Hospital of Sichuan University
Chengdu, China
Daqing General Oil Field Hospital
Daqing, China
Guangdong Cardiovascular Institute of Guangdong Provincial Hospital
Guangzhou, China
Guangdong Nanfang Hospital
Guangzhou, China
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, China
Nanjing First Hospital
Nanjing, China
Shanghai 6th People's Hospital, Jiaotong University
Shanghai, China
Shanghai Chest Hospital of Jiaotong University
Shanghai, China
General Hospital of SY Military Institute
Shenyang, China
TEDA International Cardiovascular Hospital
Tianjin, China
Xijing Hospital, Fourth Military Medical University
Xi'an, China
Related Publications (1)
Gao R, Han Y, Yang Y, Zhang J, Hou Y, Wang H, Li H, Fang Q, Yu B, Xu B, Allocco DJ, Dawkins KD. PLATINUM China: a prospective, randomized investigation of the platinum chromium everolimus-eluting stent in de novo coronary artery lesions. Catheter Cardiovasc Interv. 2015 Mar;85 Suppl 1:716-23. doi: 10.1002/ccd.25859. Epub 2015 Feb 18.
PMID: 25631909DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Runlin Gao
- Organization
- Cardiovascular Institute and Fu Wai Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Yuejin Yang
Cardiovascular Institute and Fu Wai Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2011
First Posted
January 31, 2011
Study Start
January 1, 2011
Primary Completion
March 1, 2013
Study Completion
August 1, 2014
Last Updated
March 11, 2025
Results First Posted
November 20, 2024
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share