Coronary Artery DiseaseCYNERGYNCT01106378
Cynergy: the CYPHER-NEVO Registry
An observational study of Coronary Artery Disease, run by Cordis US Corp. at 3 sites in 3 countries.
Trial summary
The purpose of this registry is to compare the safety and the performance of the NEVO™ Sirolimus-eluting Coronary Stent, once commercially available, to the CYPHER Select® Plus Sirolimus-eluting Coronary Stent in complex subjects presenting with acute STEMI for primary intervention, diabetes mellitus or multi vessel… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 14,000 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2010to Dec 2011
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects treated in routine clinical practice with a NEVO™ Sirolimus-eluting Coronary Stent,once commercially available, OR a CYPHER Select® Plus Sirolimus-eluting Coronary Stent and diagnosed with acute STEMI for primary intervention and/or diabetes mellitus and/or multi vessel disease.
Who may be able to join
- Subjects treated in routine clinical practice with a NEVO™ Sirolimus-eluting Coronary Stent once commercially available, or a CYPHER Select® Plus Sirolimus-eluting Coronary Stent and diagnosed with acute STEMI for primary intervention and/or diabetes mellitus and/or multi vessel disease.
Who cannot join
- In case, during the index procedure, the subject was treated with a stent other than the CYPHER Select® Plus Sirolimus-eluting Coronary Stent or the NEVO™ Sirolimus-eluting Coronary Stent or a mix of the CYPHER Select® Plus SES and NEVO™ SES
- In case, during the index procedure, the subject was treated with other therapy (e.g. balloon angioplasty, cutting balloons, directional coronary atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc.) in segments not ultimately treated with a CYPHER Select® Plus SES or NEVO™ SES.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Brazil1 site
Instituto do Coracão do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo
About this study
Official title: Cynergy - The CYPHER-NEVO Registry. An Observational Registry, to Evaluate the Safety and Performance of the NEVO™ Sirolimus-eluting Coronary Stent in Routine Clinical Practice, and to Compare Its Safety and Performance With the CYPHER Select® Plus Sirolimus-eluting Coronary Stent (SES)
The purpose of this registry is to compare the safety and the performance of the NEVO™ Sirolimus-eluting Coronary Stent, once commercially available, to the CYPHER Select® Plus Sirolimus-eluting Coronary Stent in complex subjects presenting with acute STEMI for primary intervention, diabetes mellitus or multi vessel disease. The second purpose of this registry is to evaluate the safety and performance of the NEVO™ Sirolimus-eluting Coronary Stent, once commercially available and the CYPHER Select® Plus Sirolimus-eluting Coronary Stent in complex subjects diagnosed with acute STEMI for primary intervention, diabetes mellitus and/or multi vessel disease.
The data will be collected from subjects treated with commercially available product and following routine clinical practice. Uniform, complete and accurate data will be collected on the subject's medical history, peri-procedurally, during the index hospitalization, and during follow-up.
Read the detailed description
The CYPHER Select® Plus Sirolimus-eluting Coronary Stent (SES) is a balloon-expandable intracoronary 316L stainless steel stent with a coating that consists of a blend of Sirolimus and polymers.
Sirolimus is a potent immunosuppressive agent which has been proven to prolong graft survival in many animal models of transplantation. Sirolimus prevents both proliferation and migration of smooth muscle cells (in vivo and in vitro) in graft and balloon injury models. Furthermore, Sirolimus has been shown to be effective in reducing restenosis and the need for repeat revascularization while demonstrating superior efficacy measures such as angiographic late loss and binary restenosis.
The NEVO™ Sirolimus-eluting Coronary Stent is a cobalt-chromium alloy stent platform that incorporates two unique features: reservoir technology, and a bioresorbable polymer which prevents initial contact between the polymer and the vessel wall and chronic polymer exposure. This design minimized initial tissue exposure to polymer, and also enables polymer resorption within approximately three months.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, drug-eluting stents, sirolimus-eluting coronary stents
- 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.
| Study group | Role | What they receive |
|---|---|---|
| NEVO™ Sirolimus-eluting Coronary Stent System. | Subjects treated during routine clinical practice with the NEVO™ Sirolimus-eluting Coronary Stent System and diagnosed with acute STEMI for primary intervention and/or diabetes mellitus and/or multi vessel disease. | |
| CYPHER Select® Plus Coronary Stent | Subjects treated during routine clinical practice with the CYPHER Select® Plus Coronary Stent System and diagnosed with acute STEMI for primary intervention and/or diabetes mellitus and/or multi vessel disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority comparison of Target Lesion Failure (TLF) in the NEVO group to the CYPHER group in subjects with acute STEMI, diabetes mellitus or multi vessel disease.
TLF: composite clinical endpoint of cardiac death (death that cannot be attributed to a non-cardiac cause), target vessel-related MI and clinically-driven target lesion revascularization in the NEVO group compared to the CYPHER group.
Measured: 12 months follow-up post-procedure
Secondary outcomes (8)
TLF in the NEVO and the CYPHER group
TLF: composite clinical endpoint of cardiac death (death that cannot be attributed to a non-cardiac cause), target vessel-related MI and clinically driven target lesion revascularization
Measured: Discharge, 1, 6, and 24 months follow-up post-procedure
Prescription and compliance patterns and impact of dual antiplatelet therapy (DAPT) duration on the incidence of the composite endpoint of all death, all MI and all revascularization, its individual components,stent thrombosis (ST) and major bleeding.
Measured: Duration throughout the study
Clinically driven Target Lesion Revascularization (TLR) defined as repeat PCI or CABG to the target lesion
Measured: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure
Clinically driven Target Vessel Revascularization (TVR) defined as repeat PCI or CABG to the target vessel
Measured: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure
Composite endpoint of all death, all MI, all revascularization and its individual components
Measured: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure
Incidence of ARC (Academic Research Consortium) defined (definite, probably, possible and the composite of definite and probable) early and late and very late stent thrombosis
Measured: Hospital discharge, 1,6, 12 and 24 months follow-up post-procedure
Major bleeding complications
Measured: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure.
Stroke that persists >24 hours
Stroke (cerebrovascular accident or CVA) defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists >24 hours
Measured: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2011
- Study completionDec 2011 (estimated)
Why it stopped: Early termination of patient enrollment based on business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 14,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philip Urban, MD, Principal investigator, Clinique La TourExpedito Ribeiro, MD, Principal investigator, Instituto do Coracão do Hospital das Clinicas da Faculdade de Medicina da Universidade de São PauloSeung Jung Park, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106378
- Sponsor's protocol ID
- EC09-02
- Acronym
- CYNERGY
- Status last verified
- Jul 2011
- First submitted
- 16 Apr 2010
- Last updated
- 12 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cynergy - The CYPHER-NEVO Registry. An Observational Registry, to Evaluate the Safety and Performance of the NEVO™ Sirolimus-eluting Coronary Stent in Routine Clinical Practice, and to Compare Its Safety and Performance With the CYPHER Select® Plus Sirolimus-eluting Coronary Stent (SES)
- ClinicalTrials.gov ID
- NCT01106378
- Acronym / sponsor ID
- CYNERGY / EC09-02
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, drug-eluting stents, sirolimus-eluting coronary stents
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Early termination of patient enrollment based on business decision
- Enrolment
- 14,000 participants (estimated)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2011 (estimated)
- First posted
- 19 Apr 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.
The purpose of this registry is to compare the safety and the performance of the NEVO™ Sirolimus-eluting Coronary Stent, once commercially available, to the CYPHER Select® Plus Sirolimus-eluting Coronary Stent in complex subjects presenting with acute STEMI for primary intervention, diabetes mellitus or multi vessel disease. The second purpose of this registry is to evaluate the safety and performance of the NEVO™ Sirolimus-eluting Coronary Stent, once commercially available and the CYPHER Select® Plus Sirolimus-eluting Coronary Stent in complex subjects diagnosed with acute STEMI for primary intervention, diabetes mellitus and/or multi vessel disease.
The data will be collected from subjects treated with commercially available product and following routine clinical practice. Uniform, complete and accurate data will be collected on the subject's medical history, peri-procedurally, during the index hospitalization, and during follow-up.
Detailed description
The CYPHER Select® Plus Sirolimus-eluting Coronary Stent (SES) is a balloon-expandable intracoronary 316L stainless steel stent with a coating that consists of a blend of Sirolimus and polymers.
Sirolimus is a potent immunosuppressive agent which has been proven to prolong graft survival in many animal models of transplantation. Sirolimus prevents both proliferation and migration of smooth muscle cells (in vivo and in vitro) in graft and balloon injury models. Furthermore, Sirolimus has been shown to be effective in reducing restenosis and the need for repeat revascularization while demonstrating superior efficacy measures such as angiographic late loss and binary restenosis.
The NEVO™ Sirolimus-eluting Coronary Stent is a cobalt-chromium alloy stent platform that incorporates two unique features: reservoir technology, and a bioresorbable polymer which prevents initial contact between the polymer and the vessel wall and chronic polymer exposure. This design minimized initial tissue exposure to polymer, and also enables polymer resorption within approximately three months.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEVO™ Sirolimus-eluting Coronary Stent System. | – | –Subjects treated during routine clinical practice with the NEVO™ Sirolimus-eluting Coronary Stent System and diagnosed with acute STEMI for primary intervention and/or diabetes mellitus and/or multi vessel disease. |
| CYPHER Select® Plus Coronary Stent | – | –Subjects treated during routine clinical practice with the CYPHER Select® Plus Coronary Stent System and diagnosed with acute STEMI for primary intervention and/or diabetes mellitus and/or multi vessel disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects treated in routine clinical practice with a NEVO™ Sirolimus-eluting Coronary Stent,once commercially available, OR a CYPHER Select® Plus Sirolimus-eluting Coronary Stent and diagnosed with acute STEMI for primary intervention and/or diabetes mellitus and/or multi vessel disease.
Key inclusion criteria (1 listed)
- Subjects treated in routine clinical practice with a NEVO™ Sirolimus-eluting Coronary Stent once commercially available, or a CYPHER Select® Plus Sirolimus-eluting Coronary Stent and diagnosed with acute STEMI for primary intervention and/or diabetes mellitus and/or multi vessel disease.
Key exclusion criteria (2 listed)
- In case, during the index procedure, the subject was treated with a stent other than the CYPHER Select® Plus Sirolimus-eluting Coronary Stent or the NEVO™ Sirolimus-eluting Coronary Stent or a mix of the CYPHER Select® Plus SES and NEVO™ SES
- In case, during the index procedure, the subject was treated with other therapy (e.g. balloon angioplasty, cutting balloons, directional coronary atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc.) in segments not ultimately treated with a CYPHER Select® Plus SES or NEVO™ SES.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Non-inferiority comparison of Target Lesion Failure (TLF) in the NEVO group to the CYPHER group in subjects with acute STEMI, diabetes mellitus or multi vessel disease.
Time frame: 12 months follow-up post-procedure
TLF: composite clinical endpoint of cardiac death (death that cannot be attributed to a non-cardiac cause), target vessel-related MI and clinically-driven target lesion revascularization in the NEVO group compared to the CYPHER group.
8 secondary outcomes
TLF in the NEVO and the CYPHER group
Time frame: Discharge, 1, 6, and 24 months follow-up post-procedure
Prescription and compliance patterns and impact of dual antiplatelet therapy (DAPT) duration on the incidence of the composite endpoint of all death, all MI and all revascularization, its individual components,stent thrombosis (ST) and major bleeding.
Time frame: Duration throughout the study
Clinically driven Target Lesion Revascularization (TLR) defined as repeat PCI or CABG to the target lesion
Time frame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure
Clinically driven Target Vessel Revascularization (TVR) defined as repeat PCI or CABG to the target vessel
Time frame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure
Composite endpoint of all death, all MI, all revascularization and its individual components
Time frame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure
Incidence of ARC (Academic Research Consortium) defined (definite, probably, possible and the composite of definite and probable) early and late and very late stent thrombosis
Time frame: Hospital discharge, 1,6, 12 and 24 months follow-up post-procedure
Major bleeding complications
Time frame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure.
Stroke that persists >24 hours
Time frame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure.
Results and safety
The study was stopped early (reason given: Early termination of patient enrollment based on business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
Related trials for Coronary Artery Disease
Recruiting
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Active, not recruitingObservational study
Post-Induction Low Cardiac Output Syndrome in Coronary Artery Bypass Graft Surgery
Cardiac Output, Low, Coronary Arterial Disease
RecruitingPhase 3
A Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length Of Stay In Patients With Coronary Artery Disease (CAD) Undergoing Coronary Artery Bypass Grafting (CABG) Surgery.
Coronary Artery Disease (CAD), Coronary Artery Bypass Graft Surgery(CABG)
Enrolling by invitationObservational study
Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
Non-obstructive Coronary Disease, Acute or Chronic Coronary Artery Disease
Recruiting
Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma
Melanoma
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.
Philip Urban, MD principal investigator
Clinique La Tour
Expedito Ribeiro, MD principal investigator
Instituto do Coracão do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Seung Jung Park, MD principal investigator
Asan Medical Center
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 inclusion and 2 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 12 Jul 2011. 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 Brazil, South Korea, 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.
Are results available for this study?
The study was stopped early (reason given: Early termination of patient enrollment based on business decision). 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?
Non-inferiority comparison of Target Lesion Failure (TLF) in the NEVO group to the CYPHER group in subjects with acute STEMI, diabetes mellitus or multi vessel disease. (time frame: 12 months follow-up post-procedure). 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 12 Jul 2011.