Atherosclerotic Coronary Artery DiseasePhase 3NEVO IINCT01202058
An Observational Safety Evaluation of Patients Treated With the NEVO™ Sirolimus-eluting Coronary Stent. (NEVO II)
A Phase 3 study testing NEVO™ Sirolimus-eluting Coronary Stent System and XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System) in people with Atherosclerotic Coronary Artery Disease, run by Cordis US Corp. at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Coronary Artery Disease
- What is being tested?
- NEVO™ Sirolimus-eluting Coronary Stent System and XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Aug 2010to Oct 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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.
Read the 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.
- Conditions
- Atherosclerotic Coronary Artery Disease
- Being tested
- NEVO™ Sirolimus-eluting Coronary Stent System, XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System)
- Keywords
- Coronary artery disease, Drug-eluting stents, Reservoir technology
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEVO™ Sirolimus-eluting Coronary Stent SystemDevice
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.
XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| NEVO™ SES | Experimental | 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. Receives: Device: NEVO™ Sirolimus-eluting Coronary Stent System |
| XIENCE V®/XIENCE PRIME™/PROMUS® | Active comparator | Subjects randomized to treatment with the XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System Receives: Device: XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Twelve month composite clinical endpoint of all death, all MI and all revascularizations.
Measured: 12 months
Secondary outcomes (5)
Stent thrombosis defined as definite, probable, possible and composite of definite and probable at early, late and very late time points (using ARC definition)
Measured: 60 months
Bleeding complication
Measured: 60 months
Stroke
Measured: 60 months
Device, Procedural and Lesion Success
Measured: Procedural
Composite endpoint of all death, all MI and all revascularization and its individual components
Measured: 60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2011
- Study completionOct 2012
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick W. Serruys, MD, PhD, Principal investigator, Erasmus MC - Thoraxcenter, Rotterdam, The NetherlandsStephan Windecker, MD, PhD, Principal investigator, Inselspital, Bern, SwitzerlandManel Sabate, MD, Principal investigator, Hospital Universitari Clinic de Barcelona, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202058
- Sponsor's protocol ID
- EC09-01
- Acronym
- NEVO II
- Status last verified
- Oct 2012
- First submitted
- 14 Sep 2010
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Safety Evaluation of Patients Treated With the NEVO™ Sirolimus-eluting Coronary Stent.
- ClinicalTrials.gov ID
- NCT01202058
- Acronym / sponsor ID
- NEVO II / EC09-01
- Conditions
- Atherosclerotic Coronary Artery Disease
- Keywords
- Coronary artery disease, Drug-eluting stents, Reservoir technology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEVO™ SES | Experimental | Device: NEVO™ Sirolimus-eluting Coronary Stent SystemDesign 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. |
| XIENCE V®/XIENCE PRIME™/PROMUS® | Active comparator | Device: XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System)Subjects randomized to treatment with the XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEVO™ Sirolimus-eluting Coronary Stent SystemDesign 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. | Device | NEVO™ SES |
| 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. | Device | XIENCE V®/XIENCE PRIME™/PROMUS® |
Primary outcome
Twelve month composite clinical endpoint of all death, all MI and all revascularizations.
Time frame: 12 months
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick W. Serruys, MD, PhD principal investigator
Erasmus MC - Thoraxcenter, Rotterdam, The Netherlands
Stephan Windecker, MD, PhD principal investigator
Inselspital, Bern, Switzerland
Manel Sabate, MD principal investigator
Hospital Universitari Clinic de Barcelona, Barcelona, Spain
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NEVO™ Sirolimus-eluting Coronary Stent System and XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System) in people with Atherosclerotic Coronary Artery Disease, run by Cordis US Corp. at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Twelve month composite clinical endpoint of all death, all MI and all revascularizations. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2012.