The OMEGA Clinical Trial

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01419171

Enrollment

328

Registered

2011-08-18

Start date

2011-10-31

Completion date

2014-01-31

Last updated

2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Coronary Artery Disease

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.

Interventions

DEVICEOMEGA™ 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
9-month Target Lesion Failure (TLF) Rate	Nine Month	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.

Secondary

Measure	Time frame	Description
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	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.
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	—
12 Month Non-cardiac Death Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months	—
12 Month All Death Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months	—
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	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.
12 Month All Death or MI Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months	—
12 Month All Death/MI/TVR Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months	—
12 Month Stent Thrombosis Rate (Definite or Probable by Academic Research Consortium [ARC] Definitions)	Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months	—
Periprocedural Endpoints: Technical Success Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day	Technical success: successful delivery and deployment of the study stent to the target vessel, without balloon rupture or embolization. Summarized per attempted study stent.
Clinical Procedural Success Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day	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.
12 Month Cardiac Death or MI Rate	Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months	—

Countries

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

Participant flow

Participants by arm

Arm	Count
OMEGA™ Monorail Coronary Stent System 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.	328
Total	328

Baseline characteristics

Characteristic	OMEGA™ Monorail Coronary Stent System
Age, Continuous	65.46 years STANDARD_DEVIATION 11.23
Cardiac History History of CABG	15 participants
Cardiac History History of CHF	21 participants
Cardiac History History of PCI	95 participants
Cardiac History Previous Myocardial Infarction	96 participants
Cardiac History Silent Ischemia	54 participants
Cardiac History Stable Angina	182 participants
Cardiac History Unstable Angina	111 participants
Cardiac Risk Factors Family History of CAD	131 participants
Cardiac Risk Factors Hyperlipidemia Requiring Medication	230 participants
Cardiac Risk Factors Hypertension Requiring Medication	243 participants
Cardiac Risk Factors Medically Treated Diabetes	57 participants
Cardiac Risk Factors Smoking, Ever	211 participants
Lesion Characteristic: Lesion Length 10 to 20 mm	172 Lesions
Lesion Characteristic: Lesion Length Greater than 20 mm	32 Lesions
Lesion Characteristic: Lesion Length Less than 10 mm	123 Lesions
Lesion Characteristic: Lesion Location Distal	37 Lesions
Lesion Characteristic: Lesion Location Mid	155 Lesions
Lesion Characteristic: Lesion Location Ostial	14 Lesions
Lesion Characteristic: Lesion Location Proximal	122 Lesions
Lesion Characteristic: Percent Diameter Stenosis by QCA	67.41 Percent STANDARD_DEVIATION 11.34
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow 0 (no perfusion)	0 Lesions
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow 1 (penetration with minimal perfusion)	2 Lesions
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow 2 (partial perfusion)	6 Lesions
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow 3 (complete perfusion)	319 Lesions
Lesion Characteristics Aneurysm	7 Lesions
Lesion Characteristics Calcification, Any	111 Lesions
Lesion Characteristics Thrombus	4 Lesions
Lesion Characteristics Tortuosity, Any	32 Lesions
Lesion Characteristics Ulcer	21 Lesions
Lesion Characteristics by Quantitative Cornary Angiography Lesion Length	12.49 Millimeters STANDARD_DEVIATION 5.15
Lesion Characteristics by Quantitative Cornary Angiography Minimum Lumen Diameter	0.9 Millimeters STANDARD_DEVIATION 0.38
Lesion Characteristics by Quantitative Cornary Angiography Reference Vessel Diameter	2.77 Millimeters STANDARD_DEVIATION 0.53
Lesion Characteristics: Target Lesion Vessel Circumflex Artery	79 participants
Lesion Characteristics: Target Lesion Vessel Left Anterior Descending Artery	112 participants
Lesion Characteristics: Target Lesion Vessel Right Coronary Artery	137 participants
Race/Ethnicity, Customized Black, of African heritage	9 participants
Race/Ethnicity, Customized Caucasian	254 participants
Race/Ethnicity, Customized Hispanic or Latino	2 participants
Race/Ethnicity, Customized Not disclosed	61 participants
Race/Ethnicity, Customized Other	2 participants
Region of Enrollment Belgium	37 participants
Region of Enrollment France	55 participants
Region of Enrollment Germany	31 participants
Region of Enrollment Latvia	23 participants
Region of Enrollment Netherlands	39 participants
Region of Enrollment Spain	39 participants
Region of Enrollment United States	104 participants
Sex: Female, Male Female	106 Participants
Sex: Female, Male Male	222 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	118 / 328
serious Total, serious adverse events	108 / 328

Outcome results

Primary

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.

Time frame: Nine Month

Population: N=323 (5 patients were not evaluable for the endpoint: Follow-up \< 240 days and event-free)

Arm	Measure	Value (NUMBER)
OMEGA™ Monorail Coronary Stent System	9-month Target Lesion Failure (TLF) Rate	11.5 percentage of participants

Secondary