Coronary Artery DiseasePhase 3PLATINUMNCT00823212
The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions
A Phase 3 study testing PROMUS Coronary Stent System, PROMUS Element Coronary Stent System and Aspirin in people with Coronary Artery Disease, run by Boston Scientific Corporation at 133 sites in 17 countries.
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 patients with up to 2 de novo atherosclerotic coronary artery lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- PROMUS Coronary Stent System, PROMUS Element Coronary Stent System and Aspirin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,530 participants
- Where
- 133 sitesin 17 countries
- Study dates
- Jan 2009to Dec 2014
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be at least 18 years of age
- Patient (or legal guardian) understands study requirements and treatment procedures and provides written informed consent before any study-specific tests or procedures are performed
- For patients less than 20 years of age enrolled at a Japanese site, patient and patient's legal representative must provide written informed consent before any study-specific tests or procedures are performed
- Patient is eligible for percutaneous coronary intervention (PCI)
- Patient has documented stable angina pectoris or documented silent ischemia; or unstable angina pectoris
- Patient is an acceptable candidate for coronary artery bypass grafting (CABG)
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- Patient has a left ventricular ejection fraction (LVEF) >=30% as measured within 30 days prior to enrollment
- Patient is willing to comply with all protocol-required follow-up evaluations
- Angiographic Inclusion Criteria (visual estimate):
- 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 <=4.25 mm. Target lesion length must measure (by visual estimate) <=24 mm. Target lesion must be in a major coronary artery or branch with visually estimated stenosis >=50% and <100% with Thrombolysis in Myocardial Infarction (TIMI) flow >1.
Who cannot join
- Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute myocardial infarction (MI)
- Patient has had a known diagnosis of recent MI (ie, within 72 hours prior to index procedure) and has elevated enzymes at time of index procedure as follows.
- Patients are excluded if any of the following criteria are met at time of the index procedure.
- If creatine kinase-myoglobin band (CK-MB) >2× upper limit of normal (ULN), the patient is excluded regardless of CK Total.
- If CK-MB is 1-2× ULN, the patient is excluded if the CK Total is >2× ULN.
- If CK Total/CK MB are not used and Troponin is, patients are excluded if the following criterion is met at time of index procedure.
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- Troponin >1× ULN with at least one of the following.
- Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (eg, >1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block [LBBB]);
- Development of pathological Q waves in the ECG; or
- Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
- Note: For patients with unstable angina or patients who have had a recent MI, CK Total/CK MB (or Troponin if CK Total/CK MB are not used) must be documented prior to enrolling/randomizing the patient.
- Patient has received an organ transplant or is on a waiting list for an organ transplant
- Patient is receiving or scheduled to receive chemotherapy within 30 days before or after index procedure
- Patient is receiving oral or intravenous immunosuppressive therapy (ie, inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (eg, human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
- Patient is receiving chronic (>=72 hours) anticoagulation therapy (eg, heparin, coumadin) for indications other than acute coronary syndrome
- Patient has platelet count <100,000 cells/mm3 or >700,000 cells/mm3
- Patient has white blood cell (WBC) count <3,000 cells/mm3
- Patient has documented or suspected liver disease, including laboratory evidence of hepatitis
- Patient is on dialysis or has known renal insufficiency (ie, estimated creatinine clearance <50 ml/min by the Cockcroft Gault formula, or [(140-age)*lean body weight (in kg)]/[plasma creatinine (mg/dl)*72])
- Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions
- Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
- Target vessel(s) or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to index procedure
- Target vessel(s) has been treated within 10 mm proximal or distal to target lesion (by visual estimate) with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to index procedure
- Non-target vessel or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to index procedure
- Planned or actual target vessel(s) 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 index procedure
- Patient previously treated at any time with coronary intravascular brachytherapy
- Patient has a known allergy to the study stent system or protocol-required concomitant medications (eg, stainless steel, platinum, cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be adequately premedicated
- Patient has active peptic ulcer or active gastrointestinal (GI) bleeding
- Patient has one of the following.
- Other serious medical illness (eg, cancer, congestive heart failure) that may reduce life expectancy to less than 24 months
- Current problems with substance abuse (eg, alcohol, cocaine, heroin, etc.)
- Planned procedure that may cause non-compliance with protocol or confound data interpretation
- Patient is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
- Patient intends to participate in another investigational drug or device clinical trial within 12 months after index procedure
- Patient with known intention to procreate within 12 months after 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.)
- Patient 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)
- Patient has more than 2 target lesions, or more than 1 target lesion and 1 non-target lesion, which will be treated during the index procedure
- Angiographic Exclusion Criteria (visual estimate):
- Target lesion meets any of the following criteria:
- Aorto-ostial location (ie, lesion located within 5 mm of ostium by visual estimate)
- Left main location
- Located within 5 mm of origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate
- Located within a saphenous vein graft or arterial graft
- Will be accessed via a saphenous vein graft or arterial graft
- Involves a side branch >=2.0 mm in diameter by visual estimate
- Involves a clinically significant side branch <2.0 mm in diameter by visual estimate that has a clinically significant stenosis at the ostium
- TIMI flow 0 (total occlusion) or TIMI flow 1 prior to wire crossing
- Excessive tortuosity proximal to or within the lesion
- Extreme 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 target vessel
- Non-target lesion to be treated during the index procedure meets any of the following criteria:
- Located within the target vessel
- Located within a bypass graft (venous or arterial)
- Left main location
- Chronic total occlusion
- Involves a complex bifurcation (eg, bifurcations requiring treatment with more than 1 stent)
- Restenotic from previous intervention
- Patient has unprotected left main coronary artery disease (>50% diameter stenosis)
- Patient has protected left main coronary artery disease and a target lesion in the LAD or LCX
- Patient has an additional clinically significant lesion(s) in target vessel for which an intervention within 12 months after the index procedure is likely to be required
- Patient has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate) Note: Multiple focal stenoses will be considered as a single lesion if they can be completely covered with 1 stent.
Trial locations and contacts
133 sites in 17 countries.
133 sites in 17 countries
United States75 sites
Heart Hospital of Austin
Austin, Texas, 78756
Bakersfield Memorial Hospital
Bakersfield, California, 93301
Union Memorial Hospital
Baltimore, Maryland, 21218
Baptist Medical Center Princeton
Birmingham, Alabama, 35211
Tufts Medical Center
Boston, Massachusetts, 02111
Maimonides Medical Center
Brooklyn, New York, 11219
Lankenau Institute for Medical Research
Bryn Mawr, Pennsylvania, 19010
Kaleida Health
Buffalo, New York, 14209
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
Our Lady of Lourdes Medical Center
Camden, New Jersey, 08103
Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45219
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Sisters of Charity Providence Hospital
Columbia, South Carolina, 29204
Ohio State University Medical Center
Columbus, Ohio, 43210
Ohio Health Research and Innovation Institute
Columbus, Ohio, 43214
Baylor Heart & Vascular Hospital
Dallas, Texas, 75226
Mercy Hospital Medical Center
Des Moines, Iowa, 50314
St. Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, 55805
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503
Moses H. Cone Memorial Hospital/LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, 27401
Pinnacle Health at Harrisburg Hospital
Harrisburg, Pennsylvania, 17105
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
St. Luke's Episcopal Hospital
Houston, Texas, 77030
Krannert Institute of Cardiology
Indianapolis, Indiana, 46202
St. Vincent's Hospital
Indianapolis, Indiana, 46260
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301
St. Luke's Hospital / Mid America Heart Institute
Kansas City, Missouri, 64111
Scripps Clinic
La Jolla, California, 92037
Nebraska Heart Institute
Lincoln, Nebraska, 68526
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
South Denver Cardiology Associates, PC
Littleton, Colorado, 80120
Good Samaritan Hospital
Los Angeles, California, 90017
Jewish Hospital and St. Mary's Healthcare
Louisville, Kentucky, 40202
Medical Center of the Rockies (Loveland)
Loveland, Colorado, 80538
Lynchburg General Hospital
Lynchburg, Virginia, 24501
Medical Center of Central Georgia
Macon, Georgia, 31201
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Mount Sinai School Medical Center
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
MediQuest Research Group Inc. at Munroe Regional Medical Center
Ocala, Florida, 34471
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
Florida Hospital
Orlando, Florida, 32803
Northern Michigan Hospital
Petoskey, Michigan, 49770
Banner Good Samaritan Regional Medical Center
Phoenix, Arizona, 85006
Maine Medical Center
Portland, Maine, 04102
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Wake Medical Center
Raleigh, North Carolina, 27610
Mayo Clinic Foundation
Rochester, Minnesota, 55905
St. Francis Hospital
Roslyn, New York, 11576
William Beaumont Hospital
Royal Oak, Michigan, 48073
University of California Davis Medical Center
Sacramento, California, 95817
Mercy General Hospital
Sacramento, California, 95819
Methodist Texsan Hospital
San Antonio, Texas, 78201
University of California San Diego
San Diego, California, 92103
Alvarado Hospital
San Diego, California, 92120
Firelands Regional Medical Center
Sandusky, Ohio, 44870
Swedish Medical Center
Seattle, Washington, 98122
Deaconess Medical Center
Spokane, Washington, 99204
Providence Health & Services - Washington
Spokane, Washington, 99204
Southern Illinois University Memorial Medical Center
Springfield, Illinois, 62702
St. John's Hospital
Springfield, Illinois, 62769
Baystate Medical Center
Springfield, Massachusetts, 01199
Washington University School of Medicine
St Louis, Missouri, 63110
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Washington Adventist Hospital
Takoma Park, Maryland, 20912
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
Mercy St. Vincent Medical Center
Toledo, Ohio, 43608
North Mississippi Medical Center
Tupelo, Mississippi, 38801
Trinity Mother Frances Health System
Tyler, Texas, 75701
Aspirus Heart and Vascular Institute - Research and Education
Wausau, Wisconsin, 54401
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
Japan10 sites
Sakakibara Heart Institute, Japan Research Promotion Society for Cardiovascular Diseases
Fuchu-shi, Tokyo
Teikyo University Hospital
Itabashi-ku, Tokyo
Shonan Kamakura General Hospital
Kamakura-shi, Kanagawa
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka
Toho University Ohashi Medical Center
Meguro-ku, Tokyo
The Cardiovascular Institute Hospital
Minato-ku, Tokyo
Sakurabashi Watanabe Hospital
Osaka, 530-0001
Japan Community Health Care Organization Hokkaido Hospital
Sapporo, Hokkaido
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo
Saiseikai Yokohama-City Eastern Hospital
Yokohama, Kanagawa
France6 sites
CHU de Besancon
Besançon, 25030
Clinique St. Augustin
Bordeaux, 33000
Institut Cardiovasculaire - Paris Sud / Institut Hospitalier Jacques Cartier
Massy, 91300
Clinique du Millenaire
Montpellier, 34960
Centre Hopital Universitaire Rangueil
Toulouse, 31059
Clinique Pasteur
Toulouse, 31076
Germany6 sites
Kerckhoff Klinik
Bad Nauheim, 61231
Herz-und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, 32545
Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
Bad Segeberg, 23795
Universitatsklinik Charite Berlin
Berlin, 10117
Universitat Heidelberg
Heidelberg, 69120
Herzzentrum Universitat Leipzig
Leipzig, 04289
United Kingdom6 sites
Royal Victoria Hospital
Belfast, Ireland, BT12 6BA
Golden Jubilee National Hospital
Clydebank, G81 4HX
Guys and St. Thomas NHS Foundation Trust St. Thomas Hospital
London, England, SE1 7EH
James Cook University Hospital
Middlesbrough, England, TS4 3BW
John Radcliffe Infirmary Oxford II
Oxford, England, OX3 9DU
Southampton University Hospital
Southampton, SO16 6YD
Australia4 sites
Monash Medical Centre
Clayton, Victoria, 3168
St. Vincent's Hospital
Fitzroy, Victoria, 3065
Royal Perth Hospital
Perth, 6000
The Prince Charles Hospital
Queensland, 4032
Belgium4 sites
Academisch Ziekenhuis Middelheim
Antwerp, B-2020
Ziekenhuis Oost Limburg
Genk, 3600
Universitair Ziekenhuis Gent
Ghent, B-9000
UZ Gasthuisberg
Leuven, B-3000
Netherlands4 sites
Medisch Centrum Alkmaar
Alkmaar, 1815 JD
Amphia Ziekenhuis
Breda, 4818CK
Catherina Ziekenhuis
Eindhoven, 5623 EJ
St Antonius Ziekenhuis
Nieuwegein, 3435 CM
Poland4 sites
Szpital Uniwersytecki
Bydgoszcz, 85-094
SPZOZ Szpital Uniwersytecki w Krakowie
Krakow, 31-501
National Institute of Cardiology
Warsaw, 04-628
Military Hospital
Wroclaw, 50-891
Finland3 sites
Oulu University Hospital
Oulu, 90029
Tampere University Hospital
Tampere, 33521
Turku University Hospital
Turku, 20521
New Zealand3 sites
Ascot Angiography
Auckland, 1051
Middlemore Hospital
Otahuhu, Auckland, 1640
Wellington Hospital
Wellington, 6021
Denmark2 sites
Skejby Sygehus
Aarhus, D-8200
Rigshospitalet Copenhagen
Copenhagen, 2100
Malaysia2 sites
Sarawak General Hospital
Kota Samarahan, Sarawak, 94300
Institut Jantung Negara
Kuala Lumpur, 50400
About this study
Official title: PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions
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 patients with up to 2 de novo atherosclerotic coronary artery lesions.
This clinical trial compares outcomes in patients treated with PROMUS Element to those in patients treated with a different everolimus-eluting coronary stent. The lesions are of average length in average-sized vessels ("workhorse"). A companion sub-trial evaluates outcomes in smaller vessels (SV) and another sub-trial evaluates outcomes in longer lesions (LL).
Read the detailed description
The wide-spread use of DES has evolved as standard of care in de novo lesions. The proposed study will evaluate the safety and effectiveness of PROMUS Element for the treatment of de novo atherosclerotic lesions in native coronary arteries. The study design is consistent with the draft guidance for industry titled, "Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies" (March 2008).
During the trial, thienopyridines must be administered according to the 2007 American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) guidelines, which recommended that clopidogrel (75 mg daily) or ticlopidine (250 mg twice daily) be prescribed after stent implantation for at least 6 months in all patients, and for at least 12 months in patients who are not at high risk of bleeding. For sites in the United States, the use of prasugrel is not allowed as part of the PLATINUM Clinical Trial. For sites in other countries, prasugrel may be prescribed according to its approved dosing in countries in which it is available. For patients taking aspirin daily a loading dose is recommended; for patients who have not been taking aspirin daily, aspirin must be administered as a loading dose. Patients continue to take aspirin indefinitely to reduce the risk of thrombosis.
The main study is the PLATINUM Workhorse Randomized Controlled Trial, which is registered under NCT00823212. The clinical protocol includes two companion sub-trials with smaller vessels (PLATINUM SV) and longer lesions (PLATINUM LL) plus a Pharmacokinetics sub-trial (PLATINUM PK). The three sub-trials are registered under separate NCT numbers.
- Conditions
- Coronary Artery Disease
- Being tested
- PROMUS Coronary Stent System, PROMUS Element Coronary Stent System, Aspirin, Thienopyridine
- Keywords
- drug-eluting stents, DES, atherosclerotic
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMUS Coronary Stent SystemDevice
Also called XIENCE V
PROMUS is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Coronary Stent SystemDevice
PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating that is the same as on the PROMUS [XIENCE V] stent).
AspirinDrug
Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter.
ThienopyridineDrug
Also called A brand name for clopidogrel is PLAVIX., A brand name for ticlopidine is TICLID.
Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant.
| Study group | Role | What they receive |
|---|---|---|
| PROMUS | Active comparator | Patients who received the PROMUS (XIENCE V) Everolimus-Eluting Coronary Stent Receives: Device: PROMUS Coronary Stent System; Drug: Aspirin; Drug: Thienopyridine |
| PROMUS Element | Experimental | Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent Receives: Device: PROMUS Element Coronary Stent System; Drug: Aspirin; Drug: Thienopyridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF)
Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
Measured: 12-month post index procedure
Secondary outcomes (38)
Target Lesion Failure (TLF)
TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
Measured: 30 days
Target Lesion Failure (TLF)
TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
Measured: 6 months
Target Lesion Failure (TLF)
TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
Measured: 12 months
Target Vessel Failure (TVF)
TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
Measured: 30 days
Target Vessel Failure (TVF)
TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
Measured: 6 months
Target Vessel Failure (TVF)
TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
Measured: 12 months
Myocardial Infarction (MI) Related to the Target Vessel
Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal
Measured: 30 days
Myocardial Infarction (MI) Related to the Target Vessel
Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal
Measured: 6 months
Myocardial Infarction (MI) Related to the Target Vessel
Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal
Measured: 12 months
All Cause Mortality
Measured: 30 days
All Cause Mortality
Measured: 6 months
All Cause Mortality
Measured: 12 months
Cardiac Death Related to the Target Vessel
Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded
Measured: 30 days
Cardiac Death Related to the Target Vessel
Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded
Measured: 6 months
Cardiac Death Related to the Target Vessel
Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded
Measured: 12 months
Non-cardiac Death
Defined as a death not due to cardiac causes (see definition of cardiac death above)
Measured: 30 Days
Non-cardiac Death
Defined as a death not due to cardiac causes (see definition of cardiac death above)
Measured: 6 Months
Non-cardiac Death
Defined as a death not due to cardiac causes (see definition of cardiac death above)
Measured: 12 months
Cardiac Death or Myocardial Infarction (MI)
Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above
Measured: 30 days
Cardiac Death or Myocardial Infarction (MI)
Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above
Measured: 6 months
Cardiac Death or Myocardial Infarction (MI)
Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above
Measured: 12 months
All Death or Myocardial Infarction (MI)
Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal
Measured: 30 days
All Death or Myocardial Infarction (MI)
Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal
Measured: 6 months
All Death or Myocardial Infarction (MI)
Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal
Measured: 12 months
Target Lesion Revascularization (TLR)
Target lesion revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.
Measured: 30 days
Target Lesion Revascularization (TLR)
TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.
Measured: 6 months
Target Lesion Revascularization (TLR)
TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.
Measured: 12 months
Target Vessel Revascularization (TVR)
Target vessel revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.
Measured: 30 days
Target Vessel Revascularization (TVR)
TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.
Measured: 6 months
Target Vessel Revascularization (TVR)
TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.
Measured: 12 months
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).
Measured: 24 hours
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).
Measured: >24 hr-30 days
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).
Measured: >30 days-1 year
Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
See above for definitions of MI and TVR
Measured: 30 days
Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
See above for definitions of MI and TVR.
Measured: 6 months
Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
See above for definitions of MI and TVR.
Measured: 12 months
Clinical Procedural Success
Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or cardiac death
Measured: In hospital
Acute Technical Success
Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent
Measured: Acute-At time of index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2010
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter M Maurer, MPH, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823212
- Sponsor's protocol ID
- S2046
- Other IDs
- ACTRN12608000582358
- Acronym
- PLATINUM
- Status last verified
- Mar 2019
- First submitted
- 13 Jan 2009
- Last updated
- 27 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).
Publications
Stone GW, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Allocco DJ, Dawkins KD; PLATINUM Trial Investigators. A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of Up to Two de Novo Coronary Artery Lesions) trial. J Am Coll Cardiol. 2011 Apr 19;57(16):1700-8. doi: 10.1016/j.jacc.2011.02.016. Epub 2011 Apr 4.
PubMed 21470815Kelly CR, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Rabinowitz A, Carrie D, Pompili V, Bouchard A, Saito S, Allocco DJ, Dawkins KD, Stone GW. Long-Term Safety and Efficacy of Platinum Chromium Everolimus-Eluting Stents in Coronary Artery Disease: 5-Year Results From the PLATINUM Trial. JACC Cardiovasc Interv. 2017 Dec 11;10(23):2392-2400. doi: 10.1016/j.jcin.2017.06.070.
PubMed 29217001
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT00823212
- Acronym / sponsor ID
- PLATINUM / S2046
- Conditions
- Coronary Artery Disease
- Keywords
- drug-eluting stents, DES, atherosclerotic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,530 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Jan 2009 (estimated)
- Results
- Posted 27 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 patients with up to 2 de novo atherosclerotic coronary artery lesions.
This clinical trial compares outcomes in patients treated with PROMUS Element to those in patients treated with a different everolimus-eluting coronary stent. The lesions are of average length in average-sized vessels ("workhorse"). A companion sub-trial evaluates outcomes in smaller vessels (SV) and another sub-trial evaluates outcomes in longer lesions (LL).
Detailed description
The wide-spread use of DES has evolved as standard of care in de novo lesions. The proposed study will evaluate the safety and effectiveness of PROMUS Element for the treatment of de novo atherosclerotic lesions in native coronary arteries. The study design is consistent with the draft guidance for industry titled, "Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies" (March 2008).
During the trial, thienopyridines must be administered according to the 2007 American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) guidelines, which recommended that clopidogrel (75 mg daily) or ticlopidine (250 mg twice daily) be prescribed after stent implantation for at least 6 months in all patients, and for at least 12 months in patients who are not at high risk of bleeding. For sites in the United States, the use of prasugrel is not allowed as part of the PLATINUM Clinical Trial. For sites in other countries, prasugrel may be prescribed according to its approved dosing in countries in which it is available. For patients taking aspirin daily a loading dose is recommended; for patients who have not been taking aspirin daily, aspirin must be administered as a loading dose. Patients continue to take aspirin indefinitely to reduce the risk of thrombosis.
The main study is the PLATINUM Workhorse Randomized Controlled Trial, which is registered under NCT00823212. The clinical protocol includes two companion sub-trials with smaller vessels (PLATINUM SV) and longer lesions (PLATINUM LL) plus a Pharmacokinetics sub-trial (PLATINUM PK). The three sub-trials are registered under separate NCT numbers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROMUS | Active comparator | Device: PROMUS Coronary Stent System, Drug: Aspirin, Drug: ThienopyridinePatients who received the PROMUS (XIENCE V) Everolimus-Eluting Coronary Stent |
| PROMUS Element | Experimental | Device: PROMUS Element Coronary Stent System, Drug: Aspirin, Drug: ThienopyridinePatients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient must be at least 18 years of age
- Patient (or legal guardian) understands study requirements and treatment procedures and provides written informed consent before any study-specific tests or procedures are performed
- For patients less than 20 years of age enrolled at a Japanese site, patient and patient's legal representative must provide written informed consent before any study-specific tests or procedures are performed
- Patient is eligible for percutaneous coronary intervention (PCI)
- Patient has documented stable angina pectoris or documented silent ischemia; or unstable angina pectoris
Key exclusion criteria (64 listed)
- Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute myocardial infarction (MI)
- Patient has had a known diagnosis of recent MI (ie, within 72 hours prior to index procedure) and has elevated enzymes at time of index procedure as follows.
- Note: For patients with unstable angina or patients who have had a recent MI, CK Total/CK MB (or Troponin if CK Total/CK MB are not used) must be documented prior to enrolling/randomizing the patient.
- Patient has received an organ transplant or is on a waiting list for an organ transplant
- Patient is receiving or scheduled to receive chemotherapy within 30 days before or after index procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROMUS Coronary Stent SystemAlso: XIENCE VPROMUS is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating). | Device | PROMUS |
| PROMUS Element Coronary Stent SystemPROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating that is the same as on the PROMUS [XIENCE V] stent). | Device | PROMUS Element |
| AspirinPatients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter. | Drug | PROMUS, PROMUS Element |
| ThienopyridineAlso: A brand name for clopidogrel is PLAVIX., A brand name for ticlopidine is TICLID.Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant. | Drug | PROMUS, PROMUS Element |
Primary outcome
Target Lesion Failure (TLF)
Time frame: 12-month post index procedure
Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
38 secondary outcomes
Target Lesion Failure (TLF)
Time frame: 30 days
Target Lesion Failure (TLF)
Time frame: 6 months
Target Lesion Failure (TLF)
Time frame: 12 months
Target Vessel Failure (TVF)
Time frame: 30 days
Target Vessel Failure (TVF)
Time frame: 6 months
Target Vessel Failure (TVF)
Time frame: 12 months
Myocardial Infarction (MI) Related to the Target Vessel
Time frame: 30 days
Myocardial Infarction (MI) Related to the Target Vessel
Time frame: 6 months
Myocardial Infarction (MI) Related to the Target Vessel
Time frame: 12 months
All Cause Mortality
Time frame: 30 days
All Cause Mortality
Time frame: 6 months
All Cause Mortality
Time frame: 12 months
Cardiac Death Related to the Target Vessel
Time frame: 30 days
Cardiac Death Related to the Target Vessel
Time frame: 6 months
Cardiac Death Related to the Target Vessel
Time frame: 12 months
Non-cardiac Death
Time frame: 30 Days
Non-cardiac Death
Time frame: 6 Months
Non-cardiac Death
Time frame: 12 months
Cardiac Death or Myocardial Infarction (MI)
Time frame: 30 days
Cardiac Death or Myocardial Infarction (MI)
Time frame: 6 months
Cardiac Death or Myocardial Infarction (MI)
Time frame: 12 months
All Death or Myocardial Infarction (MI)
Time frame: 30 days
All Death or Myocardial Infarction (MI)
Time frame: 6 months
All Death or Myocardial Infarction (MI)
Time frame: 12 months
Target Lesion Revascularization (TLR)
Time frame: 30 days
Target Lesion Revascularization (TLR)
Time frame: 6 months
Target Lesion Revascularization (TLR)
Time frame: 12 months
Target Vessel Revascularization (TVR)
Time frame: 30 days
Target Vessel Revascularization (TVR)
Time frame: 6 months
Target Vessel Revascularization (TVR)
Time frame: 12 months
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
Time frame: 24 hours
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
Time frame: >24 hr-30 days
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
Time frame: >30 days-1 year
Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
Time frame: 30 days
Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
Time frame: 6 months
Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
Time frame: 12 months
Clinical Procedural Success
Time frame: In hospital
Acute Technical Success
Time frame: Acute-At time of index procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21470815Stone GW, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Allocco DJ, Dawkins KD; PLATINUM Trial Investigators. A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of Up to Two de Novo Coronary Artery Lesions) trial. J Am Coll Cardiol. 2011 Apr 19;57(16):1700-8. doi: 10.1016/j.jacc.2011.02.016. Epub 2011 Apr 4.
- Derived from this study: PubMed 29217001Kelly CR, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Rabinowitz A, Carrie D, Pompili V, Bouchard A, Saito S, Allocco DJ, Dawkins KD, Stone GW. Long-Term Safety and Efficacy of Platinum Chromium Everolimus-Eluting Stents in Coronary Artery Disease: 5-Year Results From the PLATINUM Trial. JACC Cardiovasc Interv. 2017 Dec 11;10(23):2392-2400. doi: 10.1016/j.jcin.2017.06.070.
- Individual participant dataSharing planned: Undecided. The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter M Maurer, MPH study director
Boston Scientific Corporation
133 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PROMUS Coronary Stent System, PROMUS Element Coronary Stent System and Aspirin in people with Coronary Artery Disease, run by Boston Scientific Corporation at 133 sites in 17 countries.
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 10 inclusion and 64 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 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 133 sites in United States, Japan, France, Germany, United Kingdom and 12 more countries. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2012). 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?
Target Lesion Failure (TLF) (time frame: 12-month post index procedure). 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 NCT00823212, which also lists 2 linked publications.
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 27 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.