The OMEGA Clinical Trial

NCT ID: NCT01419171

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-01-31

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.

Conditions

Atherosclerosis; Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OMEGA™ Monorail Coronary Stent System

Group Type: EXPERIMENTAL

OMEGA™ Monorail Coronary Stent System

Intervention Type: DEVICE

All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.

Interventions

OMEGA™ Monorail Coronary Stent System

All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

• 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 Criteria

• 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:

1. If CK MB >2× upper limit of normal (ULN), the subject is excluded regardless of the CK Total.

2. If CK Total >2× ULN, CK-MB must be drawn and the subject is excluded if CK-MB is abnormal.

3. 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;
• 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.

• Target lesion meets any of the following criteria:

• Aorto-ostial location (i.e., lesion located within 5 mm of the ostium by visual estimate)
• Left main location
• Located within 5 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery or Right Coronary Artery (RCA) by visual estimate
• Located within a saphenous vein graft or an arterial graft
• Will be accessed via a saphenous vein graft or an arterial graft
• Involves a side branch ≥2.0 mm in diameter by visual estimate
• Involves a 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 guide 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 the target vessel
• Target lesion cannot be covered by a single study stent (unplanned bailout stenting is allowed)
• 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 (e.g., bifurcations requiring treatment with more than 1 stent)
• Requires additional unplanned stents (treatment of the non-target lesion with more than one stent is permitted as long as the stents are initially planned)
• Treatment not deemed a clinical angiographic success
• Treatment not completed prior to treatment of target lesion
• Subject has unprotected left main coronary artery disease (>50% diameter stenosis).
• Subject has protected left main coronary artery disease and a target lesion in the LAD or LCX.
• Subject has an additional clinically significant lesion(s) in the target vessel for which an intervention within 12 months after the index procedure may be required.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Maurer, MPH

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

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

H-Hartziekenhuis Roeselare-Menen vzw

Roeselare, , Belgium

Centre Hôpital Universitaire Rangueil

Toulouse, Cedex 9, France

Hospitaux du Haut Leveque

Pessac, Cedex, France

Clinique Pasteur

Toulouse, , France

Kerckhoff Heart and Thoraxcenter

Bad, Nauheim, Germany

Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

Bad Segeberg, , Germany

Universitaetsklinikum Heidelberg

Heidelberg, , Germany

P. Stradins University Hospital

Riga, , Latvia

Catharina Ziekenhuis

Eindhoven, , Netherlands

Acadmisch Ziekehus

Maastricht, , Netherlands

Haga Ziekenhuis locatie Leyweg

The Hague, , Netherlands

Hospital Clinico Y Provincial

Barcelona, , Spain

Countries

United States; Belgium; France; Germany; Latvia; Netherlands; Spain

References

Wang JC, Carrie D, Masotti M, Erglis A, Mego D, Watkins MW, Underwood P, Allocco DJ, Hamm CW. Primary endpoint results of the OMEGA Study: One-year clinical outcomes after implantation of a novel platinum chromium bare metal stent. Cardiovasc Revasc Med. 2015 Mar;16(2):65-9. doi: 10.1016/j.carrev.2014.12.007. Epub 2014 Dec 23.

Reference Type: DERIVED

PMID: 25576273 (View on PubMed)

Other Identifiers

S2215

Identifier Type: -

Identifier Source: org_study_id