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

Primary Purpose

Atherosclerotic Coronary Artery Disease

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NEVO™ Sirolimus-eluting Coronary Stent System
XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System)
Sponsored by
Cordis Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerotic Coronary Artery Disease focused on measuring Coronary artery disease, Drug-eluting stents, Reservoir technology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Erasmus MC - Thoraxcenter
  • Hospital Universitari Clinic de Barcelona
  • Inselspital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NEVO™ SES

XIENCE V®/XIENCE PRIME™/PROMUS®

Arm Description

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.

Subjects randomized to treatment with the XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System

Outcomes

Primary Outcome Measures

Twelve month composite clinical endpoint of all death, all MI and all revascularizations.

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)
Bleeding complication
Stroke
Device, Procedural and Lesion Success
Composite endpoint of all death, all MI and all revascularization and its individual components

Full Information

First Posted
September 14, 2010
Last Updated
October 24, 2012
Sponsor
Cordis Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01202058
Brief Title
An Observational Safety Evaluation of Patients Treated With the NEVO™ Sirolimus-eluting Coronary Stent. (NEVO II)
Acronym
NEVO II
Official Title
An Observational Safety Evaluation of Patients Treated With the NEVO™ Sirolimus-eluting Coronary Stent.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
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.
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cordis Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerotic Coronary Artery Disease
Keywords
Coronary artery disease, Drug-eluting stents, Reservoir technology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NEVO™ SES
Arm Type
Experimental
Arm Description
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.
Arm Title
XIENCE V®/XIENCE PRIME™/PROMUS®
Arm Type
Active Comparator
Arm Description
Subjects randomized to treatment with the XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System
Intervention Type
Device
Intervention Name(s)
NEVO™ Sirolimus-eluting Coronary Stent System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Twelve month composite clinical endpoint of all death, all MI and all revascularizations.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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
Title
Bleeding complication
Time Frame
60 months
Title
Stroke
Time Frame
60 months
Title
Device, Procedural and Lesion Success
Time Frame
Procedural
Title
Composite endpoint of all death, all MI and all revascularization and its individual components
Time Frame
60 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick W. Serruys, MD, PhD
Organizational Affiliation
Erasmus MC - Thoraxcenter, Rotterdam, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephan Windecker, MD, PhD
Organizational Affiliation
Inselspital, Bern, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manel Sabate, MD
Organizational Affiliation
Hospital Universitari Clinic de Barcelona, Barcelona, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus MC - Thoraxcenter
City
Rotterdam
Country
Netherlands
Facility Name
Hospital Universitari Clinic de Barcelona
City
Barcelona
Country
Spain
Facility Name
Inselspital
City
Bern
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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