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AtherosclerosisNCT01419171

The OMEGA Clinical Trial

A study testing OMEGA™ Monorail Coronary Stent System in people with Atherosclerosis and Coronary Artery Disease, run by Boston Scientific Corporation at 37 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atherosclerosis, Coronary Artery Disease
What is being tested?
OMEGA™ Monorail Coronary Stent System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
328 participants
Where
37 sitesin 7 countries
Study dates
Oct 2011to Jan 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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])
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  • 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 Exclusion Criteria:
  • 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.

Trial locations and contacts

37 sites in 7 countries.

37 sites in 7 countries

United States22 sites

  • Presbyterian Hospital

    Albuquerque, New Mexico, 87106

  • Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • Our Lady of Lourdes Medical Center

    Cherry Hill, New Jersey, 08034

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

    Cincinnati, Ohio, 45219

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • St. Mary's Duluth Clinic Regional Heart Center

    Duluth, Minnesota, 55805

  • National Park Medical Center

    Hot Springs, Arkansas, 71901

  • St. Mary's Medical Center

    Huntington, West Virginia, 25701

  • St. Vincent's Hospital

    Indianapolis, Indiana, 46260

  • St. Joseph Hospital

    Lexington, Kentucky, 40504

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120

  • Florida Hospital

    Orlando, Florida, 32803

  • Presbyterian University of Pennsylvania Medical Center

    Philidelphia, Pennsylvania, 01910

  • Wake Medical Center

    Raleigh, North Carolina, 27610

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Southern Illinois University-Memorial Medical Center

    Springfield, Illinois, 62702

  • The Toledo Hospital

    Toledo, Ohio, 43606

  • Mercy St. Vincent Medical Center

    Toledo, Ohio, 43608

Other trials in United States

Belgium4 sites

  • Imelda Ziekenhuis

    Bonheiden, 2820

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Virga Jesse Ziekenhuis

    Hasselt, 3500

  • H-Hartziekenhuis Roeselare-Menen vzw

    Roeselare, 8800

Other trials in Belgium

France3 sites

  • Hospitaux du Haut Leveque

    Pessac, Cedex, 33604

  • Centre Hôpital Universitaire Rangueil

    Toulouse, Cedex 9, 31059

  • Clinique Pasteur

    Toulouse, 31076

Other trials in France

Germany3 sites

  • Kerckhoff Heart and Thoraxcenter

    Bad, Nauheim, 61231

  • Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

    Bad Segeberg, 23795

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

Other trials in Germany

Netherlands3 sites

  • Catharina Ziekenhuis

    Eindhoven, 5623 EJ

  • Acadmisch Ziekehus

    Maastricht, 6202AZ

  • Haga Ziekenhuis locatie Leyweg

    The Hague, 2545 CH

Other trials in Netherlands

Latvia1 site

  • P. Stradins University Hospital

    Riga, LV-1002

Other trials in Latvia

Spain1 site

  • Hospital Clinico Y Provincial

    Barcelona, 08036

Other trials in Spain

About this study

Official title: OMEGA: A Prospective, Multicenter Single-Arm Trial to Assess the OMEGA™ Coronary Stent System for the Treatment of a Single De Novo Coronary Artery Lesion

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.

Being tested
OMEGA™ Monorail Coronary Stent System
Medical subject headings
Atherosclerosis, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OMEGA™ Monorail Coronary Stent SystemDevice

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

Study groups in NCT01419171
Study groupRoleWhat they receive
OMEGA™ Monorail Coronary Stent SystemExperimentalNot described
Receives: Device: OMEGA™ Monorail Coronary Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Nine Month

Secondary outcomes (13)

  1. 12 Month Target Lesion Revascularization (TLR) Rate

    Any ischemia-driven repeat percutaneous coronary intervention (PCI), to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.

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

  2. 12 Month Target Vessel Revascularization (TVR) Rate

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

  3. 12 Month Target Vessel Failure (TVF) Rate

    Target vessel failure is any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.

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

  4. 12 Month Myocardial Infarction (MI)(Q-wave and Non-Q-wave) Rate

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

  5. 12 Month Cardiac Death Rate

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

  6. 12 Month Non-cardiac Death Rate

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

  7. 12 Month All Death Rate

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

  8. 12 Month Cardiac Death or MI Rate

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

  9. 12 Month All Death or MI Rate

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

  10. 12 Month All Death/MI/TVR Rate

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

  11. 12 Month Stent Thrombosis Rate (Definite or Probable by Academic Research Consortium [ARC] Definitions)

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

  12. Periprocedural Endpoints: Technical Success Rate

    Technical success: successful delivery and deployment of the study stent to the target vessel, without balloon rupture or embolization. Summarized per attempted study stent.

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day

  13. Clinical Procedural Success Rate

    Clinical Procedural Success: lesion diameter stenosis < 30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death. Summarized per patient.

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionOct 2013
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
328 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01419171
Sponsor's protocol ID
S2215
Status last verified
Sep 2014
First submitted
16 Aug 2011
Last updated
25 Sep 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 25576273

Questions about this trial

What is this clinical trial studying?

A study testing OMEGA™ Monorail Coronary Stent System in people with Atherosclerosis and Coronary Artery Disease, run by Boston Scientific Corporation at 37 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 57 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Belgium, France, Germany, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

9-month Target Lesion Failure (TLF) Rate (time frame: Nine Month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01419171, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.

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