The OMEGA Clinical Trial

NCT01419171 | Completed Results

• 1 other identifier: S2215
• Study Type: interventional
• Target: 328
• Locations: 7 countries
• Sites: 37

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

Outcome Measures

Primary Outcomes (1)

• 9-month Target Lesion Failure (TLF) Rate

  The primary endpoint is 9-month target lesion failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), Myocardial Infarction (MI) (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.

  Nine Month

Secondary Outcomes (13)

• 12 Month Target Lesion Revascularization (TLR) Rate

  Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months

• 12 Month Target Vessel Revascularization (TVR) Rate

  Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months

• 12 Month Target Vessel Failure (TVF) Rate

  Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months

• 12 Month Myocardial Infarction (MI)(Q-wave and Non-Q-wave) Rate

  Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months

• 12 Month Cardiac Death Rate

  Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months

Study Arms (1)

OMEGA™ Monorail Coronary Stent System

EXPERIMENTAL

Device: OMEGA™ Monorail Coronary Stent System

Interventions

OMEGA™ Monorail Coronary Stent System DEVICE

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

OMEGA™ Monorail Coronary Stent System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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;
• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (37)

National Park Medical Center

Hot Springs, Arkansas, 71901, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Southern Illinois University-Memorial Medical Center

Springfield, Illinois, 62702, United States

Location

St. Vincent's Hospital

Indianapolis, Indiana, 46260, United States

Location

St. Joseph Hospital

Lexington, Kentucky, 40504, United States

Location

Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

St. Mary's Duluth Clinic Regional Heart Center

Duluth, Minnesota, 55805, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Our Lady of Lourdes Medical Center

Cherry Hill, New Jersey, 08034, United States

Location

Presbyterian Hospital

Albuquerque, New Mexico, 87106, United States

Location

Wake Medical Center

Raleigh, North Carolina, 27610, United States

Location

The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

The Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Mercy St. Vincent Medical Center

Toledo, Ohio, 43608, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

Location

Presbyterian University of Pennsylvania Medical Center

Philidelphia, Pennsylvania, 01910, United States

Location

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

St. Mary's Medical Center

Huntington, West Virginia, 25701, United States

Location

Imelda Ziekenhuis

Bonheiden, 2820, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Virga Jesse Ziekenhuis

Hasselt, 3500, Belgium

Location

H-Hartziekenhuis Roeselare-Menen vzw

Roeselare, 8800, Belgium

Location

Centre Hôpital Universitaire Rangueil

Toulouse, Cedex 9, 31059, France

Location

Hospitaux du Haut Leveque

Pessac, Cedex, 33604, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Kerckhoff Heart and Thoraxcenter

Bad, Nauheim, 61231, Germany

Location

Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

P. Stradins University Hospital

Riga, LV-1002, Latvia

Location

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

Acadmisch Ziekehus

Maastricht, 6202AZ, Netherlands

Location

Haga Ziekenhuis locatie Leyweg

The Hague, 2545 CH, Netherlands

Location

Hospital Clinico Y Provincial

Barcelona, 08036, Spain

Location

Related Publications (1)

• 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.

  PMID: 25576273 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Results Point of Contact

• Title: Peter Maurer, Director Clinical Trials
• Organization: Peter Maurer, Director Clinical Trials

Peter.Maurer@bsci.com

508-683-6678

Study Officials

• Peter Maurer, MPH

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: August 18, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2014
• Last Updated: September 25, 2014
• Results First Posted: August 15, 2014

Record last verified: 2014-09

Locations

LA (1); FR (3); DE (3); BE (4); NL (3); ES (1); US (22)