An Observational Safety Evaluation of Patients Treated With the NEVO™ Sirolimus-eluting Coronary Stent. (NEVO II) (NEVO II)
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.
|Atherosclerotic Coronary Artery Disease||Device: NEVO™ Sirolimus-eluting Coronary Stent System Device: XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||An Observational Safety Evaluation of Patients Treated With the NEVO™ Sirolimus-eluting Coronary Stent.|
- Twelve month composite clinical endpoint of all death, all MI and all revascularizations. [ Time Frame: 12 months ]
- Stent thrombosis defined as definite, probable, possible and composite of definite and probable at early, late and very late time points (using ARC definition) [ Time Frame: 60 months ]
- Bleeding complication [ Time Frame: 60 months ]
- Stroke [ Time Frame: 60 months ]
- Device, Procedural and Lesion Success [ Time Frame: Procedural ]
- Composite endpoint of all death, all MI and all revascularization and its individual components [ Time Frame: 60 Months ]
|Study Start Date:||August 2010|
|Study Completion Date:||October 2012|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Experimental: NEVO™ SES
Design Protocol Am3.0 - safety follow-up:
The study population consists of 103 subjects with atherosclerotic coronary artery disease treated with the NEVO™ SES. Candidates for the initial NEVO II Study must have met ALL inclusion criteria and NO exclusion criteria.
Design Original Protocol
Subjects randomized to treatment with the NEVO™ Sirolimus-eluting Coronary Stent System.
Device: NEVO™ Sirolimus-eluting Coronary Stent System
Design Original Protocol
Intervention will consist of percutaneous coronary intervention for treatment of a single or multiple coronary lesion(s) using standard coronary intervention techniques. Intervention in this arm will include treatment with the NEVO™ Sirolimus-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.
Active Comparator: XIENCE V®/XIENCE PRIME™/PROMUS®
Subjects randomized to treatment with the XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System
Device: XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System)
Intervention will consist of percutaneous coronary intervention for treatment of a single or multiple coronary lesion(s) using standard coronary intervention techniques. Intervention in this arm will include treatment with the XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202058
|Erasmus MC - Thoraxcenter|
|Hospital Universitari Clinic de Barcelona|
|Principal Investigator:||Patrick W. Serruys, MD, PhD||Erasmus MC - Thoraxcenter, Rotterdam, The Netherlands|
|Principal Investigator:||Stephan Windecker, MD, PhD||Inselspital, Bern, Switzerland|
|Principal Investigator:||Manel Sabate, MD||Hospital Universitari Clinic de Barcelona, Barcelona, Spain|