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Prospective, Randomized, Multicenter Trial to Assess PROMUS™ Element™ Stent | Clinical Trials | Clareo Health

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Prospective, Randomized, Multicenter Trial to Assess PROMUS™ Element™ Stent

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

NCT01285999•Boston Scientific Corporation

View on ClinicalTrials.gov

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.

Detailed Description

A prospective, multi-center, randomized-controlled, single-blind, superiority trial at up to 15 sites in China to enroll 500 subjects (3:1 randomization PROMUS Element to TAXUS Liberté) with a single de novo lesion \<38mm in length (by visual estimate) in a native coronary artery ≥2.50mm to ≤4.00 mm in diameter (by visual estimate).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
+1 more criteria

Exclusion Criteria

•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)
+38 more criteria

Locations (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

Key Dates

Start Date

January 1, 2011

Primary Completion Date

March 1, 2013

Completion Date

August 1, 2014

Last Updated

March 11, 2025

Enrollment

500

ACTUAL participants

Conditions

AtherosclerosisCoronary Artery Disease

Interventions

PROMUS Element Coronary Stent System

DEVICE

TAXUS Liberté Coronary Stent System

DEVICE

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

NCT01143454

Metabolic DiseaseObesity+4 more

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RECRUITINGPHASE3

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

NCT07241390

Atherosclerosis Cardiovascular DiseaseChronic Kidney Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Prospective, Randomized, Multicenter Trial to Assess PROMUS™ Element™ Stent

Inclusion Criteria

Exclusion Criteria

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

A Study of Implantation of CRENEOUS ENTERPRISE 2 Intracranial Stent in Participants With Severe Symptomatic Intracranial Atherosclerotic Stenosis

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

Machine Learning for Handheld Vascular Studies

"Erectile Function After PCI in MI and Non-MI Patients"