An Observational Safety Evaluation of Patients Treated With the NEVO™ Sirolimus-eluting Coronary Stent. (NEVO II)

This study has been terminated.
(The NEVO™ stent will not be commercialized. Cordis decided to close the study after 1 years. This decision took the absence of safety signals into account.)
Sponsor:
Information provided by (Responsible Party):
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT01202058
First received: September 14, 2010
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: An Observational Safety Evaluation of Patients Treated With the NEVO™ Sirolimus-eluting Coronary Stent.

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • Twelve month composite clinical endpoint of all death, all MI and all revascularizations. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Bleeding complication [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
  • Device, Procedural and Lesion Success [ Time Frame: Procedural ] [ Designated as safety issue: No ]
  • Composite endpoint of all death, all MI and all revascularization and its individual components [ Time Frame: 60 Months ] [ Designated as safety issue: Yes ]

Enrollment: 156
Study Start Date: August 2010
Study Completion Date: October 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202058

Locations
Netherlands
Erasmus MC - Thoraxcenter
Rotterdam, Netherlands
Spain
Hospital Universitari Clinic de Barcelona
Barcelona, Spain
Switzerland
Inselspital
Bern, Switzerland
Sponsors and Collaborators
Cordis Corporation
Investigators
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
  More Information

No publications provided

Responsible Party: Cordis Corporation
ClinicalTrials.gov Identifier: NCT01202058     History of Changes
Other Study ID Numbers: EC09-01
Study First Received: September 14, 2010
Last Updated: October 24, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Bundestinstitut fur Arzneimittel und Medizinprodukte, BfArM
Israel: Israeli Health Ministry Pharmaceutical Administration
Latvia: State Agency of Medicines
Netherlands: Dutch Health Care Inspectorate
Switzerland: Swissmedic
Italy: Dipartimento dell'Innovazione
Spain: Jefe de Servicio Investigaciones Clinicas con productos sanitarios

Keywords provided by Cordis Corporation:
Coronary artery disease
Drug-eluting stents
Reservoir technology

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 15, 2014