Clinical trial NCT01419171: The OMEGA Clinical Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Coronary Artery Disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2011-08-18
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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.

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;
     * 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.

Primary outcomes:
measure: 9-month Target Lesion Failure (TLF) Rate
timeFrame: Nine Month
Secondary outcomes:
measure: 12 Month Target Lesion Revascularization (TLR) Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
measure: 12 Month Target Vessel Revascularization (TVR) Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
measure: 12 Month Target Vessel Failure (TVF) Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
measure: 12 Month Myocardial Infarction (MI)(Q-wave and Non-Q-wave) Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
measure: 12 Month Cardiac Death Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
measure: 12 Month Non-cardiac Death Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
measure: 12 Month All Death Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
measure: 12 Month Cardiac Death or MI Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
measure: 12 Month All Death or MI Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
measure: 12 Month All Death/MI/TVR Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
measure: 12 Month Stent Thrombosis Rate (Definite or Probable by Academic Research Consortium [ARC] Definitions)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
measure: Periprocedural Endpoints: Technical Success Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: Clinical Procedural Success Rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: National Park Medical Center
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Springfield
country: United States
facility: Southern Illinois University-Memorial Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent's Hospital
state: Indiana
city: Lexington
country: United States
facility: St. Joseph Hospital
state: Kentucky
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Duluth
country: United States
facility: St. Mary's Duluth Clinic Regional Heart Center
state: Minnesota
city: St. Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Cherry Hill
country: United States
facility: Our Lady of Lourdes Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: Presbyterian Hospital
state: New Mexico
city: Raleigh
country: United States
facility: Wake Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Toledo
country: United States
facility: Mercy St. Vincent Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Philidelphia
country: United States
facility: Presbyterian University of Pennsylvania Medical Center
state: Pennsylvania
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Hasselt
country: Belgium
facility: Virga Jesse Ziekenhuis
city: Roeselare
country: Belgium
facility: H-Hartziekenhuis Roeselare-Menen vzw
city: Toulouse
country: France
facility: Centre Hôpital Universitaire Rangueil
state: Cedex 9
city: Pessac
country: France
facility: Hospitaux du Haut Leveque
state: Cedex
city: Toulouse Cedex 3
country: France
facility: Clinique Pasteur
city: Bad
country: Germany
facility: Kerckhoff Heart and Thoraxcenter
state: Nauheim
city: Bad Segeberg
country: Germany
facility: Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Riga
country: Latvia
facility: P. Stradins University Hospital
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis locatie Leyweg
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Maastricht
country: Netherlands
facility: Acadmisch Ziekehus
city: Barcelona
country: Spain
facility: Hospital Clinico Y Provincial
Study officials:
affiliation: Boston Scientific Corporation
name: Peter Maurer, MPH
role: STUDY_DIRECTOR
References:
citation: 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.