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
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 14000
Study Start Date: April 2010
Estimated Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106378

Locations
Brazil
Instituto do Coracão do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Switzerland
Clinique La Tour
Meyrin, Switzerland
Sponsors and Collaborators
Cordis Corporation
Investigators
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
  More Information

No publications provided

Responsible Party: Hans-Peter Stoll, MD, PhD, Cordis Corporation
ClinicalTrials.gov Identifier: NCT01106378     History of Changes
Other Study ID Numbers: EC09-02
Study First Received: April 16, 2010
Last Updated: July 11, 2011
Health Authority: Bulgaria: Bulgarian Drug Agency
Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by Cordis Corporation:
Coronary artery disease
drug-eluting stents
sirolimus-eluting coronary stents

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014