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

Completed · Not applicable

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. The lesions can be located in vessels that are smaller than average-sized.

Key facts

Study ID

NCT01498692

Run by

Boston Scientific Corporation

People needed

94

Starts

2009-02-01

Expected to finish

2015-05-01

Last updated by the study team

2019-03-26

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 ≥2.25 mm and <2.5 mm. Target lesion length must measure ≤28 mm by visual estimate. Target lesion must be located 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

• Bakersfield Memorial Hospital — Bakersfield, California, United States
• Mediquest Research at Munroe Regional Medical Center — Ocala, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• St. John's Hospital — Springfield, Illinois, United States
• Jewish Hospital & St. Mary's Healthcare — Louisville, Kentucky, United States
• Northern Michigan Hospital — Petoskey, Michigan, United States
• Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
• Moses H. Cone Memorial Hospital/LeBauer Cardiovascular Research Foundation — Greensboro, North Carolina, United States
• Wake Medical Center — Raleigh, North Carolina, United States
• Lindner Center for Research and Education at The Christ Hospital — Cincinnati, Ohio, United States
• Ohio Health Research and Innovation Institute — Columbus, Ohio, United States
• Oklahoma Foundation for Cardiovascular Research — Oklahoma City, Oklahoma, United States
• Baylor Heart & Vascular Hospital — Dallas, Texas, United States
• TexSAn Heart Hospital — San Antonio, Texas, United States
• St. Vincent's Hospital — Fitzroy, Victoria, Australia
• Monash Medical Centre — Clayton, Australia
• Ziekenhuis Oost Limburg — Genk, Belgium
• UZ Gasthuisberg — Leuven, Belgium
• Centre Hôpital Universitaire Rangueil — Toulouse, Cedex 9, France
• Clinique Pasteur — Toulouse, France
• Shonan Kamakura General Hospital — Kamakura-shi, Kanagawa, Japan
• Sakurabashi Watanabe Hospital — Osaka, Osaka, Japan
• North Shore Hospital — Takapuna, New Zealand

Full record on ClinicalTrials.gov

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