Clinical trial NCT01106378: Cynergy: the CYPHER-NEVO Registry
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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
drug-eluting stents
sirolimus-eluting coronary stents
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2010-04-19
Enrollment: 14000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: 12 months follow-up post-procedure
Secondary outcomes:
measure: TLF in the NEVO and the CYPHER group
timeFrame: Discharge, 1, 6, and 24 months follow-up post-procedure
measure: 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.
timeFrame: Duration throughout the study
measure: Clinically driven Target Lesion Revascularization (TLR) defined as repeat PCI or CABG to the target lesion
timeFrame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure
measure: Clinically driven Target Vessel Revascularization (TVR) defined as repeat PCI or CABG to the target vessel
timeFrame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure
measure: Composite endpoint of all death, all MI, all revascularization and its individual components
timeFrame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure
measure: 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
timeFrame: Hospital discharge, 1,6, 12 and 24 months follow-up post-procedure
measure: Major bleeding complications
timeFrame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure.
measure: Stroke that persists >24 hours
timeFrame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coracão do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Meyrin
country: Switzerland
facility: Clinique La Tour
Study officials:
affiliation: Clinique La Tour
name: Philip Urban, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto do Coracão do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
name: Expedito Ribeiro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Seung Jung Park, MD
role: PRINCIPAL_INVESTIGATOR
References: