The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions

Completed · Phase 3

Conditions studied: Coronary Artery Disease

In brief

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).

Key facts

Study ID

NCT00823212

Run by

Boston Scientific Corporation

People needed

1530

Starts

2009-01-01

Expected to finish

2014-12-01

Last updated by the study team

2019-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• 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.

You may not qualify if…

• 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.
• 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

Where it is running

• Banner Good Samaritan Regional Medical Center — Phoenix, Arizona, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Bakersfield Memorial Hospital — Bakersfield, California, United States
• Scripps Clinic — La Jolla, California, United States
• Good Samaritan Hospital — Los Angeles, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Mercy General Hospital — Sacramento, California, United States
• University of California San Diego — San Diego, California, United States
• Alvarado Hospital — San Diego, California, United States
• South Denver Cardiology Associates, PC — Littleton, Colorado, United States
• Medical Center of the Rockies (Loveland) — Loveland, Colorado, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• MediQuest Research Group Inc. at Munroe Regional Medical Center — Ocala, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Tallahassee Memorial Hospital — Tallahassee, Florida, United States
• Medical Center of Central Georgia — Macon, Georgia, United States
• Southern Illinois University Memorial Medical Center — Springfield, Illinois, United States
• St. John's Hospital — Springfield, Illinois, United States
• Krannert Institute of Cardiology — Indianapolis, Indiana, United States
• St. Vincent's Hospital — Indianapolis, Indiana, United States
• Mercy Hospital Medical Center — Des Moines, Iowa, United States
• Jewish Hospital and St. Mary's Healthcare — Louisville, Kentucky, United States
• Maine Medical Center — Portland, Maine, United States
• Union Memorial Hospital — Baltimore, Maryland, United States
• Baptist Medical Center Princeton — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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