The OMEGA Clinical Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: OMEGA™ Monorail Coronary Stent System
|
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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 Cardiac 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 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.
Eligibility Criteria
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:
-
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;
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Park Medical Center | Hot Springs | Arkansas | United States | 71901 |
| 2 | Arkansas Heart Hospital | Little Rock | Arkansas | United States | 72211 |
| 3 | Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
| 4 | Florida Hospital | Orlando | Florida | United States | 32803 |
| 5 | Sarasota Memorial Hospital | Sarasota | Florida | United States | 34239 |
| 6 | Southern Illinois University-Memorial Medical Center | Springfield | Illinois | United States | 62702 |
| 7 | St. Vincent's Hospital | Indianapolis | Indiana | United States | 46260 |
| 8 | St. Joseph Hospital | Lexington | Kentucky | United States | 40504 |
| 9 | Union Memorial Hospital | Baltimore | Maryland | United States | 21218 |
| 10 | St. Mary's Duluth Clinic Regional Heart Center | Duluth | Minnesota | United States | 55805 |
| 11 | Regions Hospital | St. Paul | Minnesota | United States | 55101 |
| 12 | Our Lady of Lourdes Medical Center | Cherry Hill | New Jersey | United States | 08034 |
| 13 | Presbyterian Hospital | Albuquerque | New Mexico | United States | 87106 |
| 14 | Wake Medical Center | Raleigh | North Carolina | United States | 27610 |
| 15 | The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital | Cincinnati | Ohio | United States | 45219 |
| 16 | Ohio State University Medical Center | Columbus | Ohio | United States | 43210 |
| 17 | The Toledo Hospital | Toledo | Ohio | United States | 43606 |
| 18 | Mercy St. Vincent Medical Center | Toledo | Ohio | United States | 43608 |
| 19 | Oklahoma Heart Hospital | Oklahoma City | Oklahoma | United States | 73120 |
| 20 | Presbyterian University of Pennsylvania Medical Center | Philidelphia | Pennsylvania | United States | 01910 |
| 21 | Fletcher Allen Health Care | Burlington | Vermont | United States | 05401 |
| 22 | St. Mary's Medical Center | Huntington | West Virginia | United States | 25701 |
| 23 | Imelda Ziekenhuis | Bonheiden | Belgium | 2820 | |
| 24 | Universitair Ziekenhuis Gent | Gent | Belgium | 9000 | |
| 25 | Virga Jesse Ziekenhuis | Hasselt | Belgium | 3500 | |
| 26 | H-Hartziekenhuis Roeselare-Menen vzw | Roeselare | Belgium | 8800 | |
| 27 | Centre Hôpital Universitaire Rangueil | Toulouse | Cedex 9 | France | 31059 |
| 28 | Hospitaux du Haut Leveque | Pessac | Cedex | France | 33604 |
| 29 | Clinique Pasteur | Toulouse Cedex 3 | France | 31076 | |
| 30 | Kerckhoff Heart and Thoraxcenter | Bad | Nauheim | Germany | 61231 |
| 31 | Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH | Bad Segeberg | Germany | 23795 | |
| 32 | Universitaetsklinikum Heidelberg | Heidelberg | Germany | 69120 | |
| 33 | P. Stradins University Hospital | Riga | Latvia | LV-1002 | |
| 34 | Haga Ziekenhuis locatie Leyweg | Den Haag | Netherlands | 2545 CH | |
| 35 | Catharina Ziekenhuis | Eindhoven | Netherlands | 5623 EJ | |
| 36 | Acadmisch Ziekehus | Maastricht | Netherlands | 6202AZ | |
| 37 | Hospital Clinico Y Provincial | Barcelona | Spain | 08036 |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Study Director: Peter Maurer, MPH, Boston Scientific Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S2215
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | OMEGA™ Monorail Coronary Stent System |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 328 |
| COMPLETED | 328 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | OMEGA™ Monorail Coronary Stent System |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 328 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
65.46
(11.23)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
106
32.3%
|
| Male |
222
67.7%
|
| Race/Ethnicity, Customized (participants) [Number] | |
| Black, of African heritage |
9
2.7%
|
| Caucasian |
254
77.4%
|
| Hispanic or Latino |
2
0.6%
|
| Other |
2
0.6%
|
| Not disclosed |
61
18.6%
|
| Region of Enrollment (participants) [Number] | |
| France |
55
16.8%
|
| United States |
104
31.7%
|
| Spain |
39
11.9%
|
| Belgium |
37
11.3%
|
| Netherlands |
39
11.9%
|
| Latvia |
23
7%
|
| Germany |
31
9.5%
|
| Cardiac History (participants) [Number] | |
| Previous Myocardial Infarction |
96
29.3%
|
| History of CABG |
15
4.6%
|
| History of PCI |
95
29%
|
| History of CHF |
21
6.4%
|
| Stable Angina |
182
55.5%
|
| Unstable Angina |
111
33.8%
|
| Silent Ischemia |
54
16.5%
|
| Cardiac Risk Factors (participants) [Number] | |
| Smoking, Ever |
211
64.3%
|
| Medically Treated Diabetes |
57
17.4%
|
| Hyperlipidemia Requiring Medication |
230
70.1%
|
| Hypertension Requiring Medication |
243
74.1%
|
| Family History of CAD |
131
39.9%
|
| Lesion Characteristics: Target Lesion Vessel (participants) [Number] | |
| Left Anterior Descending Artery |
112
34.1%
|
| Circumflex Artery |
79
24.1%
|
| Right Coronary Artery |
137
41.8%
|
| Lesion Characteristic: Lesion Location (Lesions) [Number] | |
| Proximal |
122
|
| Mid |
155
|
| Distal |
37
|
| Ostial |
14
|
| Lesion Characteristic: Lesion Length (Lesions) [Number] | |
| Less than 10 mm |
123
|
| 10 to 20 mm |
172
|
| Greater than 20 mm |
32
|
| Lesion Characteristics (Lesions) [Number] | |
| Tortuosity, Any |
32
|
| Thrombus |
4
|
| Calcification, Any |
111
|
| Ulcer |
21
|
| Aneurysm |
7
|
| Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow (Lesions) [Number] | |
| 0 (no perfusion) |
0
|
| 1 (penetration with minimal perfusion) |
2
|
| 2 (partial perfusion) |
6
|
| 3 (complete perfusion) |
319
|
| Lesion Characteristics by Quantitative Cornary Angiography (Millimeters) [Mean (Standard Deviation) ] | |
| Reference Vessel Diameter |
2.77
(0.53)
|
| Minimum Lumen Diameter |
0.9
(0.38)
|
| Lesion Length |
12.49
(5.15)
|
| Lesion Characteristic: Percent Diameter Stenosis by QCA (Percent) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Percent] |
67.41
(11.34)
|
Outcome Measures
| Title | 9-month Target Lesion Failure (TLF) Rate |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| N=323 (5 patients were not evaluable for the endpoint: Follow-up < 240 days and event-free) |
| Arm/Group Title | OMEGA™ Monorail Coronary Stent System |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 323 |
| Number (95% Confidence Interval) [percentage of participants] |
11.5
3.5%
|
| Title | 12 Month Target Lesion Revascularization (TLR) Rate |
|---|---|
| Description | 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. |
| Time Frame | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure. |
| Arm/Group Title | OMEGA™ Monorail Coronary Stent System |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 322 |
| Number (95% Confidence Interval) [percentage of participants] |
8.4
2.6%
|
| Title | 12 Month Target Vessel Revascularization (TVR) Rate |
|---|---|
| Description | |
| Time Frame | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure. |
| Arm/Group Title | OMEGA™ Monorail Coronary Stent System |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 322 |
| Number (95% Confidence Interval) [percentage of participants] |
9.9
3%
|
| Title | 12 Month Target Vessel Failure (TVF) Rate |
|---|---|
| Description | 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. |
| Time Frame | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure. |
| Arm/Group Title | OMEGA™ Monorail Coronary Stent System |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 322 |
| Number (95% Confidence Interval) [percentage of participants] |
13.8
4.2%
|
| Title | 12 Month Myocardial Infarction (MI)(Q-wave and Non-Q-wave) Rate |
|---|---|
| Description | |
| Time Frame | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure. |
| Arm/Group Title | OMEGA™ Monorail Coronary Stent System |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 322 |
| Number (95% Confidence Interval) [percentage of participants] |
4.0
1.2%
|
| Title | 12 Month Cardiac Death Rate |
|---|---|
| Description | |
| Time Frame | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure. |
| Arm/Group Title | OMEGA™ Monorail Coronary Stent System |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 322 |
| Number (95% Confidence Interval) [percentage of participants] |
1.2
0.4%
|
| Title | 12 Month Non-cardiac Death Rate |
|---|---|
| Description | |
| Time Frame | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure. |
| Arm/Group Title | OMEGA™ Monorail Coronary Stent System |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 322 |
| Number (95% Confidence Interval) [percentage of participants] |
0.6
0.2%
|
| Title | 12 Month All Death Rate |
|---|---|
| Description | |
| Time Frame | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure. |
| Arm/Group Title | OMEGA™ Monorail Coronary Stent System |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 322 |
| Number (95% Confidence Interval) [percentage of participants] |
1.9
0.6%
|
| Title | 12 Month Cardiac Death or MI Rate |
|---|---|
| Description | |
| Time Frame | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure. |
| Arm/Group Title | OMEGA™ Monorail Coronary Stent System |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 322 |
| Number (95% Confidence Interval) [percentage of participants] |
5.3
1.6%
|
| Title | 12 Month All Death or MI Rate |
|---|---|
| Description | |
| Time Frame | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure. |
| Arm/Group Title | OMEGA™ Monorail Coronary Stent System |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 322 |
| Number (95% Confidence Interval) [percentage of participants] |
5.9
1.8%
|
| Title | 12 Month All Death/MI/TVR Rate |
|---|---|
| Description | |
| Time Frame | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure. |
| Arm/Group Title | OMEGA™ Monorail Coronary Stent System |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 322 |
| Number (95% Confidence Interval) [percentage of participants] |
14.3
4.4%
|
| Title | 12 Month Stent Thrombosis Rate (Definite or Probable by Academic Research Consortium [ARC] Definitions) |
|---|---|
| Description | |
| Time Frame | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure. |
| Arm/Group Title | OMEGA™ Monorail Coronary Stent System |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 314 |
| Number (95% Confidence Interval) [percentage of participants] |
0.6
0.2%
|
| Title | Periprocedural Endpoints: Technical Success Rate |
|---|---|
| Description | Technical success: successful delivery and deployment of the study stent to the target vessel, without balloon rupture or embolization. Summarized per attempted study stent. |
| Time Frame | Participants will be followed for the duration of hospital stay, an expected average of 1 day |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | OMEGA™ Monorail Coronary Stent System |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 328 |
| Measure Stents Attempted | 337 |
| Number (95% Confidence Interval) [percentage of patients] |
98.5
|
| Title | Clinical Procedural Success Rate |
|---|---|
| Description | 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. |
| Time Frame | Participants will be followed for the duration of hospital stay, an expected average of 1 day |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | OMEGA™ Monorail Coronary Stent System |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 328 |
| Number (95% Confidence Interval) [percentage of patients] |
95.4
|
Adverse Events
| Time Frame | Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 12 months. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | OMEGA™ Monorail Coronary Stent System | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| OMEGA™ Monorail Coronary Stent System | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| OMEGA™ Monorail Coronary Stent System | ||
| Affected / at Risk (%) | # Events | |
| Total | 108/328 (32.9%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 2/328 (0.6%) | 2 |
| Iron deficiency anaemia | 1/328 (0.3%) | 1 |
| Cardiac disorders | ||
| Acute coronary syndrome | 1/328 (0.3%) | 1 |
| Acute myocardial infarction | 4/328 (1.2%) | 4 |
| Angina pectoris | 28/328 (8.5%) | 29 |
| Angina unstable | 16/328 (4.9%) | 16 |
| Aortic valve stenosis | 1/328 (0.3%) | 1 |
| Atrial fibrillation | 5/328 (1.5%) | 5 |
| Atrial flutter | 1/328 (0.3%) | 1 |
| Atrioventricular block complete | 3/328 (0.9%) | 3 |
| Bradycardia | 1/328 (0.3%) | 1 |
| Cardiac arrest | 2/328 (0.6%) | 2 |
| Cardiac asthma | 1/328 (0.3%) | 1 |
| Cardiac failure congestive | 3/328 (0.9%) | 3 |
| Cardio-respiratory arrest | 1/328 (0.3%) | 1 |
| Coronary artery disease | 2/328 (0.6%) | 2 |
| Coronary artery occlusion | 1/328 (0.3%) | 1 |
| Coronary artery stenosis | 4/328 (1.2%) | 4 |
| Coronary artery thrombosis | 2/328 (0.6%) | 2 |
| Myocardial infarction | 2/328 (0.6%) | 2 |
| Myocardial ischaemia | 3/328 (0.9%) | 3 |
| Pericarditis | 1/328 (0.3%) | 1 |
| Sick sinus syndrome | 1/328 (0.3%) | 1 |
| Ventricular extrasystoles | 1/328 (0.3%) | 1 |
| Gastrointestinal disorders | ||
| Abdominal hernia | 1/328 (0.3%) | 1 |
| Abdominal pain | 2/328 (0.6%) | 2 |
| Anal polyp | 1/328 (0.3%) | 1 |
| Colitis | 1/328 (0.3%) | 1 |
| Colitis ulcerative | 1/328 (0.3%) | 1 |
| Diarrhoea | 1/328 (0.3%) | 1 |
| Gastric ulcer | 1/328 (0.3%) | 1 |
| Gastritis | 1/328 (0.3%) | 1 |
| Gastrointestinal haemorrhage | 1/328 (0.3%) | 1 |
| Haematemesis | 1/328 (0.3%) | 1 |
| Melaena | 1/328 (0.3%) | 1 |
| Nausea | 1/328 (0.3%) | 1 |
| Pancreatitis | 1/328 (0.3%) | 1 |
| Rectal haemorrhage | 3/328 (0.9%) | 3 |
| Reflux oesophagitis | 1/328 (0.3%) | 1 |
| Vomiting | 1/328 (0.3%) | 1 |
| General disorders | ||
| Asthenia | 1/328 (0.3%) | 1 |
| Chest discomfort | 1/328 (0.3%) | 2 |
| Impaired healing | 1/328 (0.3%) | 1 |
| Non-cardiac chest pain | 10/328 (3%) | 10 |
| Hepatobiliary disorders | ||
| Cholecystitis acute | 1/328 (0.3%) | 1 |
| Gallbladder disorder | 1/328 (0.3%) | 1 |
| Immune system disorders | ||
| Drug hypersensitivity | 1/328 (0.3%) | 1 |
| Infections and infestations | ||
| Abdominal wall infection | 1/328 (0.3%) | 1 |
| Bacterial sepsis | 1/328 (0.3%) | 1 |
| Clostridium difficile colitis | 1/328 (0.3%) | 1 |
| Diverticulitis | 1/328 (0.3%) | 1 |
| Gastroenteritis | 1/328 (0.3%) | 1 |
| Osteomyelitis | 1/328 (0.3%) | 2 |
| Pneumonia | 2/328 (0.6%) | 2 |
| Injury, poisoning and procedural complications | ||
| Concussion | 1/328 (0.3%) | 1 |
| Contusion | 1/328 (0.3%) | 1 |
| Fall | 1/328 (0.3%) | 1 |
| Femur fracture | 1/328 (0.3%) | 1 |
| Limb injury | 1/328 (0.3%) | 1 |
| Lower limb fracture | 1/328 (0.3%) | 1 |
| Suture related complication | 1/328 (0.3%) | 1 |
| Vascular pseudoaneurysm | 1/328 (0.3%) | 1 |
| Wound | 1/328 (0.3%) | 1 |
| Investigations | ||
| Blood pressure abnormal | 1/328 (0.3%) | 1 |
| Cardiac enzymes increased | 1/328 (0.3%) | 1 |
| Cardiac stress test abnormal | 2/328 (0.6%) | 2 |
| Metabolism and nutrition disorders | ||
| Hypokalaemia | 1/328 (0.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Arthritis | 1/328 (0.3%) | 1 |
| Intervertebral disc protrusion | 1/328 (0.3%) | 1 |
| Lumbar spinal stenosis | 1/328 (0.3%) | 1 |
| Musculoskeletal chest pain | 1/328 (0.3%) | 1 |
| Osteoarthritis | 3/328 (0.9%) | 3 |
| Spinal osteoarthritis | 1/328 (0.3%) | 1 |
| Trigger finger | 1/328 (0.3%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| B-cell lymphoma stage IV | 1/328 (0.3%) | 1 |
| Benign mediastinal neoplasm | 1/328 (0.3%) | 1 |
| Bladder cancer | 1/328 (0.3%) | 1 |
| Breast cancer | 1/328 (0.3%) | 1 |
| Colon cancer | 1/328 (0.3%) | 1 |
| Gastric cancer | 1/328 (0.3%) | 1 |
| Lung adenocarcinoma | 1/328 (0.3%) | 1 |
| Lung neoplasm | 1/328 (0.3%) | 1 |
| Squamous cell carcinoma | 1/328 (0.3%) | 1 |
| Urethral cancer | 1/328 (0.3%) | 1 |
| Nervous system disorders | ||
| Carotid artery disease | 1/328 (0.3%) | 1 |
| Cerebral infarction | 1/328 (0.3%) | 1 |
| Cerebrovascular accident | 2/328 (0.6%) | 2 |
| Dizziness | 1/328 (0.3%) | 2 |
| Hemiplegia | 1/328 (0.3%) | 1 |
| Ischaemic stroke | 1/328 (0.3%) | 1 |
| Presyncope | 1/328 (0.3%) | 1 |
| Speech disorder | 1/328 (0.3%) | 1 |
| Syncope | 1/328 (0.3%) | 1 |
| Transient ischaemic attack | 2/328 (0.6%) | 2 |
| Psychiatric disorders | ||
| Mental status changes | 1/328 (0.3%) | 1 |
| Renal and urinary disorders | ||
| Haematuria | 2/328 (0.6%) | 2 |
| Renal artery stenosis | 1/328 (0.3%) | 1 |
| Renal impairment | 1/328 (0.3%) | 1 |
| Reproductive system and breast disorders | ||
| Prostatitis | 1/328 (0.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Acute respiratory failure | 1/328 (0.3%) | 1 |
| Dyspnoea exertional | 1/328 (0.3%) | 1 |
| Pneumonia aspiration | 1/328 (0.3%) | 1 |
| Pulmonary embolism | 2/328 (0.6%) | 2 |
| Skin and subcutaneous tissue disorders | ||
| Skin ulcer | 2/328 (0.6%) | 2 |
| Urticaria | 1/328 (0.3%) | 1 |
| Surgical and medical procedures | ||
| Cardiac pacemaker battery replacement | 1/328 (0.3%) | 1 |
| Vascular disorders | ||
| Aortic aneurysm | 1/328 (0.3%) | 1 |
| Arterial haemorrhage | 1/328 (0.3%) | 1 |
| Haematoma | 1/328 (0.3%) | 1 |
| Hypertension | 1/328 (0.3%) | 1 |
| Hypertensive crisis | 2/328 (0.6%) | 2 |
| Intermittent claudication | 1/328 (0.3%) | 1 |
| Peripheral vascular disorder | 1/328 (0.3%) | 2 |
| Thrombosis | 1/328 (0.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| OMEGA™ Monorail Coronary Stent System | ||
| Affected / at Risk (%) | # Events | |
| Total | 118/328 (36%) | |
| Cardiac disorders | ||
| Angina pectoris | 15/328 (4.6%) | 16 |
| Coronary artery dissection | 5/328 (1.5%) | 5 |
| Gastrointestinal disorders | ||
| Haemorrhoids | 4/328 (1.2%) | 4 |
| Nausea | 6/328 (1.8%) | 6 |
| General disorders | ||
| Asthenia | 8/328 (2.4%) | 8 |
| Fatigue | 4/328 (1.2%) | 5 |
| Non-cardiac chest pain | 13/328 (4%) | 13 |
| Vessel puncture site haemorrhage | 4/328 (1.2%) | 4 |
| Injury, poisoning and procedural complications | ||
| Contusion | 8/328 (2.4%) | 8 |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 4/328 (1.2%) | 4 |
| Musculoskeletal pain | 4/328 (1.2%) | 4 |
| Pain in extremity | 7/328 (2.1%) | 9 |
| Nervous system disorders | ||
| Dizziness | 5/328 (1.5%) | 6 |
| Headache | 7/328 (2.1%) | 7 |
| Respiratory, thoracic and mediastinal disorders | ||
| Dyspnoea | 12/328 (3.7%) | 13 |
| Epistaxis | 5/328 (1.5%) | 5 |
| Vascular disorders | ||
| Hypertension | 7/328 (2.1%) | 7 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Institution and Investigator shall have the right to publish the results, provided that before publishing, Institution and Investigator shall submit copies of any proposed publication or presentation to Sponsor for review at least sixty (60) days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation.
Results Point of Contact
| Name/Title | Peter Maurer, Director Clinical Trials |
|---|---|
| Organization | Peter Maurer, Director Clinical Trials |
| Phone | 508-683-6678 |
| Peter.Maurer@bsci.com |
- S2215