Status:
TERMINATED
An Observational Safety Evaluation of Patients Treated With the NEVO™ Sirolimus-eluting Coronary Stent. (NEVO II)
Lead Sponsor:
Cordis US Corp.
Conditions:
Atherosclerotic Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
As a result of the implementation of Protocol Am3.0, the design and objective of the NEVO II trial were changed to focus on the safety follow-up of the 103 NEVO™ subjects. Although this trial started ...
Detailed Description
Restenosis remains a frequent cause of late failure after initially successful coronary angioplasty occurring in as many as 20-40% of procedures performed. Loss of luminal diameter as a result of rest...
Eligibility Criteria
Inclusion
- Subject has atherosclerotic coronary artery disease with an indication for stent implantation;
- Target lesion(s) with a diameter stenosis of minimally 50% (visual estimate) OR a functional study documenting the hemodynamic relevance of the target lesion(s);
- All target lesion(s) require treatment with stents having diameters from 2.5mm to 3.5mm (visual estimate);
- Subject is ≥18 years of age;
- Subject must sign Ethics Committee approved informed consent prior to undergoing any study specific procedure;
- Subject must be willing and able to comply with specified follow-up schedule.
Exclusion
- Planned medical procedures or concomitant disease requiring modification of DAPT regimen within 6 months of enrollment into this study;
- Women of childbearing potential without negative pregnancy test within 7 days before enrollment OR women who do not agree to remain on birth control until angiographic follow-up at 13 months if applicable OR lactating women. For women of childbearing potential, requiring an acute, non-elective procedure, a verbal confirmation of non-pregnancy and birth control is sufficient;
- Currently participating in an investigational study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT01202058
Start Date
August 1 2010
End Date
October 1 2012
Last Update
October 25 2012
Active Locations (3)
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1
Erasmus MC - Thoraxcenter
Rotterdam, Netherlands
2
Hospital Universitari Clinic de Barcelona
Barcelona, Spain
3
Inselspital
Bern, Switzerland