NL-OMON32462
Withdrawn
Phase 3
A Prospective, Multi-Center, Single Arm Study of the Conor Cobalt Chromium Reservoir Based Stent (Nevo) with Sirolimus Elution in Native Coronary Artery Lesions (CP-07 protocol) - Conor RES-ELUTION II NR study
Conor Medsystems, LLC (maakt deel uit van Johnson & Johnson); contact persoon Emily Hergenreter0 sites40 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Conor Medsystems, LLC (maakt deel uit van Johnson & Johnson); contact persoon Emily Hergenreter
- Enrollment
- 40
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:;\-1 Subjects with atherosclerotic CAD ;
- •\-2 The subject must be \>/\= 18 years of age;
- •\-3 Diagnosis of angina pectoris as defined by stable angina pectoris Canadian Cardiovascular Society Classification (Class I, II, III) OR non\-ST segment elevation acute coronary syndrome (Braunwald Classification B\&C) OR OR non\-ST segment elevation myocardial infarction \>\= 48 hours from the time of study index procedure OR asymptomatic subjects with a positive stress test;
- •\-4 Indicated treatment of up to two lesions in one or two major coronary arteries (1 target lesion in each of 2 vessels or 2 target lesions in 1 vessel). The target vessel diameter must be \>/\= 2\.25mm and \-5 Target lesion length \-6 The target lesion has been successfully crossed with the intracoronary guidewire which is positioned intraluminally in the distal vessel;
- •\-7 The target lesion diameter stenosis is \>50% and \<100% based on a visual estimate.
Exclusion Criteria
- •Exclusion Criteria:;\-1 ST\-elevation MI within 72 hours prior to the index procedure and/or creatine kinase (CK) \>2 times the local laboratory upper limits of normal on the day of the index procedure;
- •\-2 The patient has undergone target vessel revascularization within 6 months prior to the intended enrolment procedure.
- •\-3 Prior stent within 5 mm of target lesion(s);
- •\-4 Ostial target lesion(s);
- •\-5 Unprotected left main coronary disease with \>/\= 50% stenosis;
- •\-6 Angiographic evidence of thrombus within target lesion(s);
- •\-7 Total coronary occlusion or TIMI grade 0 or 1 in the target vessel;
- •\-8 Bifurcation disease involving a side branch \>/\= 2 mm in diameter;
- •\-9 Target lesion(s) within a coronary bypass graft;
- •\-10 Significant calcification or angulation in the target vessel that, in the Investigator's opinion, may preclude stent delivery and deployment;
Outcomes
Primary Outcomes
Not specified
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