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Cynergy: the CYPHER-NEVO Registry (CYNERGY)

This study has been terminated.
(Early termination of patient enrollment based on business decision)
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT01106378
First received: April 16, 2010
Last updated: July 11, 2011
Last verified: July 2011

April 16, 2010
July 11, 2011
April 2010
July 2011   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
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.
  • Target lesion failure (TLF) in NEVO group [ Time Frame: 12 months follow-up post-procedure ] [ Designated as safety issue: Yes ]
    A 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 (TLF).
  • Non-inferiority comparison of the primary endpoint of the NEVO™ to the CYPHER Select® Plus group. [ Time Frame: 12 months follow-up post-procedure ] [ Designated as safety issue: Yes ]
    Non-inferiority comparison of the primary endpoint (TLF) of the NEVO ™ Sirolimus-eluting Coronary Stent to the CYPHER Select® Plus Sirolimus-eluting Coronary Stent (SES) in complex subjects presenting with acute STEMI, Diabetes Mellitus and/or Multi Vessel Disease.
Complete list of historical versions of study NCT01106378 on ClinicalTrials.gov Archive Site
  • TLF in the NEVO and the CYPHER group [ Time Frame: Discharge, 1, 6, and 24 months follow-up post-procedure ] [ Designated as safety issue: Yes ]
    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
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure. ] [ Designated as safety issue: Yes ]
  • Stroke that persists >24 hours [ Time Frame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure. ] [ Designated as safety issue: Yes ]
    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
  • TLF in NEVO and in CYPHER group [ Time Frame: Discharge, 1, 6, 12 (only CYPHER) and 24 months follow-up post-procedure ] [ Designated as safety issue: Yes ]
    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
  • Prescription and compliance patterns and impact of dual antiplatelet therapy (DAPT) duration on MACE, ST and major bleeding. [ Time Frame: Duration throughout the study ] [ Designated as safety issue: No ]
    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 (MACE), its individual components, stent thrombosis (ST) and major bleeding
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Death (cardiac and non-cardiac) [ Time Frame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction [ Time Frame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure ] [ Designated as safety issue: Yes ]
  • Incidence of ARC (Academic Research Consortium) defined (definite, probably, possible) early and late stent thrombosis [ Time Frame: Hospital discharge, 1,6, 12 and 24 months follow-up post-procedure ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure. ] [ Designated as safety issue: Yes ]
  • Stroke that persists >24 hours [ Time Frame: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure. ] [ Designated as safety issue: Yes ]
    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
Not Provided
Not Provided
 
Cynergy: the CYPHER-NEVO Registry
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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Coronary Artery Disease
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14000
December 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Korea, Republic of,   Switzerland
 
NCT01106378
EC09-02
No
Hans-Peter Stoll, MD, PhD, Cordis Corporation
Cordis Corporation
Not Provided
Principal Investigator: Philip Urban, MD Clinique La Tour
Principal Investigator: Expedito Ribeiro, MD Instituto do Coracão do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Principal Investigator: Seung Jung Park, MD Asan Medical Center
Cordis Corporation
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP