Cynergy: the CYPHER-NEVO Registry

Coronary Artery Disease Clinical Trial

— CYNERGY  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01106378
• Other study ID #: EC09-02
• Status: Terminated
• Phase: N/A
• First received: April 16, 2010
• Last updated: July 11, 2011
• Start date: April 2010
• Est. completion date: December 2011

Study information

• Verified date: July 2011
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencySerbia and Montenegro: Agency for Drugs and Medicinal Devices
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14000
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Brazil	Instituto do Coracão do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo
Korea, Republic of	Asan Medical Center	Seoul
Switzerland	Clinique La Tour	Meyrin

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Countries where clinical trial is conducted

Brazil,  Korea, Republic of,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Major bleeding complications		Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure.	Yes
Secondary	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.	Yes