Atherosclerotic Coronary Artery Disease Clinical Trial
Official title:
An Observational Safety Evaluation of Patients Treated With the NEVO™ Sirolimus-eluting Coronary Stent.
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 interventional, the remainder of the study will be observational.
The objective of this prospective, observational study is to ensure the safety and the
wellbeing of subjects treated with the NEVO™ SES.
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 restenosis has been attributed to three physiologic mechanisms: passive
elastic recoil of the vessel, geometric vessel remodeling and neointimal hyperplasia.
Coronary stents provide mechanical scaffolding that reduces restenosis by limiting the
extent of elastic recoil and late vascular remodeling. Despite these improvements, the
incidence of restenosis following coronary stent implantation occurs in 20-40% of cases.
Restenosis following stenting is primarily a result of neointimal hyperplasia.
The methodology in interventional cardiology has historically evolved from diagnostic
coronary angiography to balloon angioplasty, the use of bare metal stents, their refinement
to drug-eluting stents with a durable polymer, and is now on the verge to drug-eluting
stents with further developed drug delivery approaches such as the reservoir technology and
the use of bioresorbable polymers. While the reservoir approach may make drug delivery more
controllable, the reduction of polymer exposure to the vessel wall was designed to improve
vascular healing and reduce the occurrence of undesirable side effects such as stent
thrombosis especially on the long-term once the drug is completely eluted.
While to date, these are concepts validated preferably in pre-clinical studies, and only
limited clinical data are available to suggest efficacy and safety of the NEVO™ SES, this
study seeks to assess its clinical value in a large and unselected cohort of subjects
representing real-world contemporary treatment patterns through a non-inferiority comparison
with the most widely used DES today, the XIENCE V® / XIENCE PRIME™ / PROMUS® stent.
Between August and October 2010, 156 subjects were enrolled in the trial. Of the 156
subjects, 103 were treated with the NEVO™ Sirolimus-eluting Stent and 53 with the
comparator. Based on a small number of acute performance observations, Cordis voluntary
suspended enrollment to optimize the balloon catheter.
As a result of evolving market dynamics, and product portfolio decisions, Cordis decided in
June 2011 to no longer pursue the development of NEVO™ Sirolimus-eluting coronary stents. As
a result of this decision, the design and objective of the NEVO II trial were changed to
allow only follow-up of the 103 NEVO™ subjects.
Since the NEVO™ SES is an investigational device; the NEVO™ subjects are being followed-up
to safeguard their safety and wellbeing. The 53 subjects from the comparator arm do not need
further follow-up due to the fact that they have been treated with a commercially available
stent.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment