The OMEGA Clinical Trial

Completed · Not applicable

Conditions studied: Atherosclerosis, Coronary Artery Disease

In brief

The purpose of this study is to evaluate the safety and effectiveness of the OMEGA Coronary Stent System for the treatment of subjects with a de novo atherosclerotic coronary artery lesion.

Key facts

Study ID

NCT01419171

Run by

Boston Scientific Corporation

People needed

328

Starts

2011-10-01

Expected to finish

2014-01-01

Last updated by the study team

2014-09-25

Who can join

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

You may qualify if…

• Subject must be at least 18 years of age.
• Subject (or legal guardian) indicates understanding of 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.
• Angiographic Inclusion Criteria:
• Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥ 2.25 mm and ≤4.5 mm.
• Target lesion length must measure (by visual estimate) as follows:
• ≤28 mm for stent diameter lengths of 2.75 mm, 3.00 mm, 3.50 mm, 4.00 mm and 4.50 mm
• ≤24 mm for stent diameter lengths of 2.25 mm and 2.50 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.
• Target lesion must be successfully pre-dilated.

You may not qualify if…

• Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute myocardial infarction (MI).
• Subject with unstable angina or recent MI (clinically diagnosed within 3 days) 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:
• If CK MB >2× upper limit of normal (ULN), the subject is excluded regardless of the CK Total.
• If CK Total >2× ULN, CK-MB must be drawn and the subject is excluded if CK-MB is abnormal.
• If CK/CK-MB results are not available at the time of procedure, 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;
• Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality Note: Subjects who do not have unstable angina or recent MI must still have CK/CK-MB 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 studies.
• 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 known renal insufficiency (e.g. 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, or atherectomy) at any time prior to the index procedure.
• Non-target vessel or side branch has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 1 day prior to the index procedure.
• Note: 1 lesion in a non-target vessel may be treated during the index procedure prior to the treatment of the target (study) lesion.
• 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., stainless steel, platinum, chromium, nickel, iron, thienopyridines and acetylsalicylic acid (ASA)) and contrast (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.).

Where it is running

• National Park Medical Center — Hot Springs, Arkansas, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Florida Hospital — Orlando, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Southern Illinois University-Memorial Medical Center — Springfield, Illinois, United States
• St. Vincent's Hospital — Indianapolis, Indiana, United States
• St. Joseph Hospital — Lexington, Kentucky, United States
• Union Memorial Hospital — Baltimore, Maryland, United States
• St. Mary's Duluth Clinic Regional Heart Center — Duluth, Minnesota, United States
• Regions Hospital — Saint Paul, Minnesota, United States
• Our Lady of Lourdes Medical Center — Cherry Hill, New Jersey, United States
• Presbyterian Hospital — Albuquerque, New Mexico, United States
• Wake Medical Center — Raleigh, North Carolina, United States
• The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital — Cincinnati, Ohio, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• The Toledo Hospital — Toledo, Ohio, United States
• Mercy St. Vincent Medical Center — Toledo, Ohio, United States
• Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States
• Presbyterian University of Pennsylvania Medical Center — Philidelphia, Pennsylvania, United States
• Fletcher Allen Health Care — Burlington, Vermont, United States
• St. Mary's Medical Center — Huntington, West Virginia, United States
• Imelda Ziekenhuis — Bonheiden, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• Virga Jesse Ziekenhuis — Hasselt, Belgium

Full record on ClinicalTrials.gov

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