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XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study (XP China SAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01894152
First received: July 1, 2013
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011.

This prospective, observational, open-label, multi-center, single-arm, post-approval study is designed to evaluate the continued safety and effectiveness of the XIENCE PRIME EECSS in a cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in real-world settings in China.

This study has no primary outcome measure. All observations are of equal weight.


Condition Intervention
Angioplasty
Cardiovascular Disease
Chronic Coronary Occlusion
Coronary Artery Bypass Graft (CABG)
Coronary Artery Disease
Coronary Heart Disease
Coronary Restenosis
Myocardial Infarction
Myocardial Ischemia
Stent Thrombosis
Vascular Disease
Device: XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluate the Continued Safety and Effectiveness of the XIENCE PRIME EECSS in a Cohort of Real-world Patients Receiving the XIENCE PRIME EECSS During Commercial Use.

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non-Qwave) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Composite rate of all death and all myocardial infarction (MI) (Q-wave and non-Q-wave) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Target lesion failure (TLF): the composite rate of cardiac death, target vessel MI (TVMI), and ischemia-driven target lesion revascularization (ID-TLR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Target lesion failure (TLF): the composite rate of cardiac death, target vessel MI (TVMI), and ischemia-driven target lesion revascularization (ID-TLR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Target lesion failure (TLF): the composite rate of cardiac death, target vessel MI (TVMI), and ischemia-driven target lesion revascularization (ID-TLR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Target lesion failure (TLF): the composite rate of cardiac death, target vessel MI (TVMI), and ischemia-driven target lesion revascularization (ID-TLR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Target lesion failure (TLF): the composite rate of cardiac death, target vessel MI (TVMI), and ischemia-driven target lesion revascularization (ID-TLR) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemiadriven target vessel revascularization (ID-TVR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemiadriven target vessel revascularization (ID-TVR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemiadriven target vessel revascularization (ID-TVR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemiadriven target vessel revascularization (ID-TVR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemiadriven target vessel revascularization (ID-TVR) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] definition) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] definition) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] definition) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] definition) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] definition) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, and non-cardiovascular) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, and non-cardiovascular) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, and non-cardiovascular) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, and non-cardiovascular) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, and non-cardiovascular) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave and non-Q-wave) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave and non-Q-wave) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave and non-Q-wave) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave and non-Q-wave) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave and non-Q-wave) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG]) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG]) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG]) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG]) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary Artery Bypass Graft [CABG]) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 2060
Study Start Date: July 2013
Estimated Study Completion Date: July 2019
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Device: XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in realworld settings in China.

Criteria

Inclusion Criteria:

  • The patient must be at least 18 years of age at the time of signing the informed consent.
  • The patient or his/her legally-authorized representative signs the EC-approved Informed Consent Form (ICF).
  • Only XIENCE PRIME stent(s) is (are) implanted during the index procedure.

Exclusion Criteria:

  • No other exclusion criteria are specified for this study.
  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: NCT01894152

Locations
United States, California
Abbott Vascular
Santa Clara, California, United States, 95054
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Junbo Ge, MB, MSc, MD, FACC, FESC, FSCAI Fudan University
Principal Investigator: Yundai Chen, MD, PhD Chinese PLA General Hospital
Principal Investigator: Fang Chen, MD Anzhen Hospital
  More Information

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01894152     History of Changes
Other Study ID Numbers: 12-396
Study First Received: July 1, 2013
Last Updated: August 6, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Abbott Vascular:
XIENCE PRIME EECSS
XIENCE V EECSS
XIENCE PRIME
SPIRIT PRIME
XIENCE PRIME SV (Small Vessel)
XIENCE PRIME LL (Long Lesion)
Coronary Artery Disease
Coronary Artery Bypass Graft (CABG)
Coronary Heart Disease
Cardiovascular Disease
Myocardial Infarction
Stent Thrombosis

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Coronary Occlusion
Coronary Restenosis
Heart Diseases
Infarction
Myocardial Infarction
Myocardial Ischemia
Thrombosis
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Coronary Stenosis
Embolism and Thrombosis
Ischemia
Necrosis
Pathologic Processes
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014