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AtherosclerosisPTChinaNCT01285999

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

A study testing PROMUS Element Coronary Stent System and TAXUS Liberté Coronary Stent System in people with Atherosclerosis and Coronary Artery Disease, run by Boston Scientific Corporation at 15 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atherosclerosis, Coronary Artery Disease
What is being tested?
PROMUS Element Coronary Stent System and TAXUS Liberté Coronary Stent System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
15 sitesChina
Study dates
Jan 2011to Aug 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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)
Show all 50Show fewer
  • Development of pathological Q waves in the ECG or;
  • Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality Note: Subjects who do not have recent MI or unstable angina must still have CK/CK-MB or troponin drawn prior to the index procedure. However, the results for these subjects do not need to be available prior to the index procedure and there are no exclusion criteria based on these laboratory studies.
  • 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
  • Subject has active peptic ulcer disease, an active gastrointestinal (GI) bleed, other bleeding diathesis or coagulopathy or will refuse transfusions
  • Subject has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
  • Target vessel (including side branches) has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index procedure
  • Target vessel has been treated within 10 mm proximal or distal to the target lesion (by visual estimate) with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to the index procedure
  • Non-target vessel has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to the index procedure
  • Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter immediately prior to stent placement
  • Planned PCI or CABG after the index procedure
  • Subject previously treated at any time with coronary intravascular brachytherapy
  • Subject has known allergy to the study stent system or protocol-required concomitant medications (e.g., everolimus, paclitaxel or structurally related compounds; fluoropolymers; thienopyridines or aspirin; contrast; acrylic; stainless steel; platinum; chromium; nickel; iron; tungsten) that cannot be adequately premedicated
  • Subject has any other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 12 months
  • Subject has current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
  • Subject has a planned procedure that may cause non-compliance with the protocol or confound data interpretation
  • Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint or intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
  • Subject with known intention to procreate within 12 month 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 month after the index procedure.)
  • 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.)
  • Subject has more than 1 lesion that requires treatment during the index procedure
  • Angiographic Exclusion Criteria:
  • Target lesion meets any of the following criteria:
  • Left main location
  • Located within 5 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery or Right Coronary Artery (RCA) by visual estimate
  • Located within a saphenous vein graft or an arterial graft
  • Will be accessed via a saphenous vein graft or an arterial graft
  • Involves a side branch ≥2.0 mm in diameter by visual estimate
  • Involves a side branch <2.0 mm in diameter by visual estimate which requires treatment
  • TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
  • Excessive tortuosity proximal to or within the lesion
  • Excessive angulation proximal to or within the lesion
  • Target lesion and/or target vessel proximal to the target lesion is moderately to severely calcified by visual estimate
  • Restenotic from previous intervention
  • Thrombus, or possible thrombus, present in the target vessel
  • Target lesion cannot be covered by a single study stent (unplanned bailout stenting is allowed)
  • Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
  • Subject has protected left main coronary artery disease (>50% diameter stenosis in the left main coronary artery (LMCA) with bypass graft[s] to the left coronary artery) and a target lesion in the LAD or LCX
  • Subject has an additional clinically significant lesion(s) for which an intervention within 12 months after the index procedure may be required

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • Cardiovascular Institute and Fu Wai Hospital

    Beijing

  • Peking Union Medical College Hospital

    Beijing

  • Peking University First Hospital

    Beijing

  • The Chinese People's Liberation Army General Hospital

    Beijing

  • Huaxi Hospital of Sichuan University

    Chengdu

  • Daqing General Oil Field Hospital

    Daqing

  • Guangdong Cardiovascular Institute of Guangdong Provincial Hospital

    Guangzhou

  • Guangdong Nanfang Hospital

    Guangzhou

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin

  • Nanjing First Hospital

    Nanjing

  • Shanghai 6th People's Hospital, Jiaotong University

    Shanghai

  • Shanghai Chest Hospital of Jiaotong University

    Shanghai

  • General Hospital of SY Military Institute

    Shenyang

  • TEDA International Cardiovascular Hospital

    Tianjin

  • Xijing Hospital, Fourth Military Medical University

    Xi'an

Other trials in China

About this study

Official title: 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

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.

Read the 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).

Being tested
PROMUS Element Coronary Stent System, TAXUS Liberté Coronary Stent System
Medical subject headings
Atherosclerosis, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PROMUS Element Coronary Stent SystemDevice

    Everolimus-eluting Coronary Stent Drug-eluting Stent (DES) implantation

  • TAXUS Liberté Coronary Stent SystemDevice

    Paclitaxel-eluting Coronary Stent Drug-eluting Stent (DES) implantation

Study groups in NCT01285999
Study groupRoleWhat they receive
PROMUS ElementExperimentalPROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
Receives: Device: PROMUS Element Coronary Stent System
TAXUS Liberté DESActive comparatorTAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
Receives: Device: TAXUS Liberté Coronary Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 9 Months

Secondary outcomes (15)

  1. Target Vessel Failure (TVF) Rate

    Measured: In hospital and at 2 years

  2. Target Lesion Revascularization (TLR) Rate

    Measured: In hospital and at 2 years

  3. Target Vessel Revascularization (TVR) Rate

    Measured: In hospital and at 2 years

  4. Target Lesion Failure (TLF) Rate

    Measured: In hospital and at 2 years

  5. Major Adverse Cardiac Event (MACE) Rate

    Measured: In hospital and at 2 years

  6. Myocardial Infarction (MI)(Q-wave and Non-Q-wave) Rate

    Measured: In hospital and at 2 years

  7. Cardiac Death Rate

    Measured: In hospital and at 2 years

  8. Non-cardiac Death Rate

    Measured: In hospital and at 2 years

  9. All Death Rate

    Measured: In hospital and at 2 years

  10. Cardiac Death or MI Rate

    Measured: In hospital and at 2 years

  11. Stent Thrombosis Rate (Definite or Probable by Academic Research Consortium [ARC] Definitions)

    Measured: In hospital and at 2 years

  12. Angiographic Endpoints: In-stent and In-segment Percent Diameter Stenosis (%DS), In-segment Late Loss , In-stent and In-segment Minimum Lumen Diameter (MLD)

    Measured: 9 months

  13. Periprocedural Endpoints: Technical Success Rate, Clinical Procedural Success Rate

    Measured: In hospital

  14. Angiographic Endpoints: In-stent and In-segment Binary Restenosis Rate, Stent Fracture Rate

    Measured: 9 month

  15. Minimal Lumen Diameter (QCA), Acute Gain (QCA)

    Measured: In hospital

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionMar 2013
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01285999
Sponsor's protocol ID
S2227
Acronym
PTChina
Status last verified
Mar 2025
First submitted
25 Jan 2011
Last updated
11 Mar 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25631909

Questions about this trial

What is this clinical trial studying?

A study testing PROMUS Element Coronary Stent System and TAXUS Liberté Coronary Stent System in people with Atherosclerosis and Coronary Artery Disease, run by Boston Scientific Corporation at 15 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 50 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

9 Month In-stent Late Loss (time frame: 9 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01285999, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.

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