XIENCE PRIME Everolimus Eluting Coronary Stent Post Marketing Surveillance (PMS) in Japan
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Angina
- Sponsor
- Abbott Medical Devices
- Enrollment
- 536
- Locations
- 1
- Primary Endpoint
- Number of Participants With Subacute Stent Thrombosis (ST)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation.
Detailed Description
The primary objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation by Pharmaceuticals and Medical Devices Agency (PMDA).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with ischemic heart disease who are eligible for treatment with XIENCE PRIME Everolimus Eluting Stent
- •Patient provides Informed Consent Form
Exclusion Criteria
- •If it is known at the time of index procedure that the patient is not able to return for the 8-month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient should not be registered in the PMS.
Outcomes
Primary Outcomes
Number of Participants With Subacute Stent Thrombosis (ST)
Time Frame: Subacute (>24 hours to 30 days)
Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation), or very late (\>1 year post stent implantation).
Number of Participants With Acute Stent Thrombosis (ST)
Time Frame: Time Frame: Acute (0-24 hours)
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).
Number of Participants With Late Stent Thrombosis (ST)
Time Frame: Late (>30 days to 1 year)
Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation), or very late (\>1 year post stent implantation).
Total Number of Participants With Overall Stent Thrombosis
Time Frame: 1 year post index procedure
Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation), or very late (\>1 year post stent implantation).
Secondary Outcomes
- Success Rate: Percentage of Participants With Implant Success Rate by Device(Participants will be followed for the duration of hospital stay, an average of 5 days)
- Success Rate: Percentage of Participants With Procedural Success by Lesion(Participants will be followed for the duration of hospital stay, an average of 5 days)
- Number of Participants With Target Vessel Failure (TVF)(3 year post index procedure)
- Number of Participants With Target Lesion Revascularization (TLR)(3 year post index procedure)
- Success Rate: Percentage of Participants With Clinical Success by Patient (Per Patient Base)(Participants will be followed for the duration of hospital stay, an average of 5 days)
- Number of Participants With All Death/All MI/All Revascularization (DMR)(4 year post index procedure)
- Number of Participants With Target Vessel Failure(TVF)(4 year post index procedure)
- Number of Participants With Target Lesion Failure (TLF)(4 year post index procedure)
- Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)(4 year post index procedure)
- Number of Participants With Death or Myocardial Infarction (MI)(4 year post index procedure)
- Number of Participants With Cardiac Death or Myocardial Infarction (MI)(4 year post index procedure)
- Number of Participants With Target Lesion Revascularization(TLR)(4 year post index procedure)
- Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)(4 year post index procedure)
- Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)(4 year post index procedure)
- Number of Participants With Myocardial Infarction (MI)(4 year post index procedure)
- Number of Participants With Non-Target Vessel Revascularization (Non-TVR)(4 year post index procedure)
- Number of Participants With All Revascularization(4 year post index procedure)
- Percent Diameter Stenosis (%DS)(8 months post index procedure)
- Number of of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)(1 year post index procedure)
- Number of Participants With Target Vessel Revascularization (TLR or TVR ( Non-TLR))(1 year post index procedure)
- Acute Gain: In-stent, In-segment(8 months post index procedure)
- Net Gain: In-stent, In-segment(8 months post index procedure)
- Late Loss(LL): In-stent, In-segment, Proximal, and Distal(8 months post index procedure)
- Number of Participants With Non-Target Lesion Revascularization (Non-TLR)(4 year post index procedure)
- Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))(4 year post index procedure)
- Number of Participants Experienced Bleeding(4 year post index procedure)