Angina Coronary artery plaque
Conditions
Interventions
All patients will undergo a coronography and an Omega study stent will be
implanted.
Sponsors
Boston Scientific Europe
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: CI1.Subject must be at least 18 years of age. CI2.Subject indicates understanding of the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed. CI3.Subject is eligible for percutaneous coronary intervention (PCI) CI4.Subject has symptomatic coronary artery disease or documented silent ischemia. CI5.Subject is an acceptable candidate for coronary artery bypass grafting (CABG). CI6.Subject has a left ventricular ejection fraction (LVEF) *30% as measured within 60 days prior to enrollment. CI7.Subject is willing to comply with all protocol-required follow-up evaluations. AI1.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. AI2.Target lesion length must measure (by visual estimate) as follows: o 28 mm for stent diameter lengths of 2.75 mm, 3.00 mm, 3.50 mm, 4.00 mm and 4.50 mm. o 24 mm for stent diameter lengths of 2.25 mm and 2.50 mm. AI3.Target lesion must be in a major coronary artery or branch with visually estimated stenosis *50% and 1. AI4.Target lesion must be successfully pre-dilated.
Exclusion criteria
Exclusion criteria: CE1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI. CE2. Subject with unstable angina or recent MI (clinically diagnosed within 3 days) must have CK/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 the 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 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. CE3. Subject is receiving chronic (*72 hours) anticoagulation therapy (e.g., heparin, coumadin) for indications other than acute coronary syndrome. CE4. Subject has a platelet count 700,000 cells/mm3. CE5. Subject has a white blood cell (WBC) count 2.0 mg/dL). CE8. Subject has active peptic ulcer disease, an active gastrointestinal (GI) bleed, other bleeding diathesis or coagulopathy or will refuse transfusions. CE9. 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. CE10. 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. CE11. 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. CE12. 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: One lesion in a non-target vessel may be treated during the index procedure prior to the treatment of the target (study) lesion. CE13. 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. CE14. Planned PCI or CABG after the index procedure. CE15. Subject previously treated at any time with coronary intravascular brachytherapy. CE16. Subject has known allergy to the study stent system or protocol-required concomitant medications (e.g., stainless
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is nine-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 |
|---|---|
| Clinical endpoints measured in hospital and at 30 days, 9 months and 12 months: * TLR rate * TLF rate (primary endpoint at 9 months) * Target vessel revascularization (TVR) rate * Target vessel failure (TVF) rate * MI (Q-wave and non*Q-wave) rate * Cardiac death rate * Non-cardiac death rate * All death rate * Cardiac death or MI rate * All death or MI rate * All death/MI/TVR rate * Stent thrombosis rate (definite or probable by Academic Research Consortium [ARC] definitions) Periprocedural endpoints: * Technical success rate * Clinical procedural success rate | — |
Countries
Netherlands
Outcome results
None listed