Cynergy: the CYPHER-NEVO Registry (CYNERGY)

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease

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 Type: Observational
• Enrollment (Anticipated): 14000

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center
• Switzerland
  • Meyrin, Switzerland
    • Clinique La Tour

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion criteria:

- 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.

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months follow-up post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.		Duration throughout the study
Clinically driven Target Lesion Revascularization (TLR) defined as repeat PCI or CABG to the target lesion		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		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		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		Hospital discharge, 1,6, 12 and 24 months follow-up post-procedure
Major bleeding complications		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	Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure.

Collaborators and Investigators

• Sponsor: Cordis Corporation
• Investigators: Principal Investigator: Seung Jung Park, MD, Asan Medical Center; Principal Investigator: Philip Urban, MD, Clinique La Tour; Principal Investigator: Expedito Ribeiro, MD, Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: April 16, 2010
• First Submitted That Met QC Criteria: April 16, 2010
• First Posted (Estimate): April 19, 2010

Study Record Updates

• Last Update Posted (Estimate): July 12, 2011
• Last Update Submitted That Met QC Criteria: July 11, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Coronary artery disease; drug-eluting stents; sirolimus-eluting coronary stents
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: EC09-02