Status:
COMPLETED
The OMEGA Clinical Trial
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Atherosclerosis
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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.).
- 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 is female of childbearing potential with a positive pregnancy test within 14 days before the index procedure, is lactating, or intends to become pregnant during the study.
- Subject has more than 1 target lesion, or more than 1 target lesion and 1 non-target lesion, which will be treated during the index procedure.
- Angiographic
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT01419171
Start Date
October 1 2011
End Date
January 1 2014
Last Update
September 25 2014
Active Locations (37)
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1
National Park Medical Center
Hot Springs, Arkansas, United States, 71901
2
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
3
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
4
Florida Hospital
Orlando, Florida, United States, 32803