Clinical trial NCT01721096: XIENCE PRIME Japan Post-Marketing Surveillance (PMS)
Official title: XIENCE PRIME Everolimus Eluting Coronary Stent Post Marketing Surveillance (PMS) in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angina
Coronary Occlusion
Coronary Artery Disease
Coronary Artery Stenosis
Myocardial Ischemia
Keywords: Angioplasty
Drug eluting stents
Stents
Real world
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-11-04
Enrollment: 536
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only patients in Japan, who are eligible to receive treatment for coronary arteries using the XIENCE PRIME Everolimus-Eluting Stent System are to be enrolled.

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).

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.

Primary outcomes:
measure: Number of Participants With Acute Stent Thrombosis (ST)
timeFrame: Time Frame: Acute (0-24 hours)
measure: Number of Participants With Subacute Stent Thrombosis (ST)
timeFrame: Subacute (>24 hours to 30 days)
measure: Number of Participants With Late Stent Thrombosis (ST)
timeFrame: Late (>30 days to 1 year)
measure: Total Number of Participants With Overall Stent Thrombosis
timeFrame: 1 year post index procedure
Secondary outcomes:
measure: Success Rate: Percentage of Participants With Implant Success Rate by Device
timeFrame: Participants will be followed for the duration of hospital stay, an average of 5 days
measure: Success Rate: Percentage of Participants With Procedural Success by Lesion
timeFrame: Participants will be followed for the duration of hospital stay, an average of 5 days
measure: Success Rate: Percentage of Participants With Clinical Success by Patient (Per Patient Base)
timeFrame: Participants will be followed for the duration of hospital stay, an average of 5 days
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 8 months post index procedure
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 1 year post index procedure
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 2 year post index procedure
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 3 years post index procedure
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 4 year post index procedure
measure: Number of Participants With All Death/All MI/All Revascularization (DMR)
timeFrame: 8 months post index procedure
measure: Number of Participants With All Death/All MI/All Revascularization (DMR)
timeFrame: 1 year post index procedure
measure: Number of Participants With All Death/All MI/All Revascularization (DMR)
timeFrame: 2 year post index procedure
measure: Number of Participants With All Death/All MI/All Revascularization (DMR)
timeFrame: 3 year post index procedure
measure: Number of Participants With All Death/All MI/All Revascularization (DMR)
timeFrame: 4 year post index procedure
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 8 months post index procedure
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 1 year post index procedure
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 2 year post index procedure
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 3 year post index procedure
measure: Number of Participants With Target Vessel Failure(TVF)
timeFrame: 4 year post index procedure
measure: Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)
timeFrame: 8 months post index procedure
measure: Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)
timeFrame: 1 year post index procedure
measure: Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)
timeFrame: 2 year post index procedure
measure: Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)
timeFrame: 3 year post index procedure
measure: Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)
timeFrame: 4 year post index procedure
measure: Number of Participants With Death or Myocardial Infarction (MI)
timeFrame: 8 months post index procedure
measure: Number of Participants With Death or Myocardial Infarction (MI)
timeFrame: 1 year post index procedure
measure: Number of Participants With Death or Myocardial Infarction (MI)
timeFrame: 2 year post index procedure
measure: Number of Participants With Death or Myocardial Infarction (MI)
timeFrame: 3 year post index procedure
measure: Number of Participants With Death or Myocardial Infarction (MI)
timeFrame: 4 year post index procedure
measure: Number of Participants With Cardiac Death or Myocardial Infarction (MI)
timeFrame: 8 months post index procedure
measure: Number of Participants With Cardiac Death or Myocardial Infarction (MI)
timeFrame: 1 year post index procedure
measure: Number of Participants With Cardiac Death or Myocardial Infarction (MI)
timeFrame: 2 year post index procedure
measure: Number of Participants With Cardiac Death or Myocardial Infarction (MI)
timeFrame: 3 year post index procedure
measure: Number of Participants With Cardiac Death or Myocardial Infarction (MI)
timeFrame: 4 year post index procedure
measure: Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)
timeFrame: 8 months post index procedure
measure: Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)
timeFrame: 1 year post index procedure
measure: Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)
timeFrame: 2 year post index procedure
measure: Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)
timeFrame: 3 year post index procedure
measure: Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)
timeFrame: 4 year post index procedure
measure: Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)
timeFrame: 8 months post index procedure
measure: Number of of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)
timeFrame: 1 year post index procedure
measure: Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)
timeFrame: 2 year post index procedure
measure: Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)
timeFrame: 3 year post index procedure
measure: Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)
timeFrame: 4 year post index procedure
measure: Number of Participants With Myocardial Infarction (MI)
timeFrame: 8 months post index procedure
measure: Number of Participants With Myocardial Infarction (MI)
timeFrame: 1 year post index procedure
measure: Number of Participants With Myocardial Infarction (MI)
timeFrame: 2 year post index procedure
measure: Number of Participants With Myocardial Infarction (MI)
timeFrame: 3 year post index procedure
measure: Number of Participants With Myocardial Infarction (MI)
timeFrame: 4 year post index procedure
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 8 months post index procedure
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 1 year post index procedure
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 2 year post index procedure
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 3 year post index procedure
measure: Number of Participants With Target Lesion Revascularization(TLR)
timeFrame: 4 year post index procedure
measure: Number of Participants With Non-Target Lesion Revascularization (Non-TLR)
timeFrame: 8 months post index procedure
measure: Number of Participants With Non-Target Lesion Revascularization (Non-TLR)
timeFrame: 1 year post index procedure
measure: Number of Participants With Non-Target Lesion Revascularization (Non-TLR)
timeFrame: 2 year post index procedure
measure: Number of Participants With Non-Target Lesion Revascularization (Non-TLR)
timeFrame: 3 year post index procedure
measure: Number of Participants With Non-Target Lesion Revascularization (Non-TLR)
timeFrame: 4 year post index procedure
measure: Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))
timeFrame: 8 months post index procedure
measure: Number of Participants With Target Vessel Revascularization (TLR or TVR ( Non-TLR))
timeFrame: 1 year post index procedure
measure: Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))
timeFrame: 2 year post index procedure
measure: Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))
timeFrame: 3 year post index procedure
measure: Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))
timeFrame: 4 year post index procedure
measure: Number of Participants With Non-Target Vessel Revascularization (Non-TVR)
timeFrame: 8 months post index procedure
measure: Number of Participants With Non-Target Vessel Revascularization (Non-TVR)
timeFrame: 1 year post index procedure
measure: Number of Participants With Non-Target Vessel Revascularization (Non-TVR)
timeFrame: 2 year post index procedure
measure: Number of Participants With Non-Target Vessel Revascularization (Non-TVR)
timeFrame: 3 year post index procedure
measure: Number of Participants With Non-Target Vessel Revascularization (Non-TVR)
timeFrame: 4 year post index procedure
measure: Number of Participants With All Revascularization
timeFrame: 8 months post index procedure
measure: Number of Participants With All Revascularization
timeFrame: 1 year post index procedure
measure: Number of Participants With All Revascularization
timeFrame: 2 year post index procedure
measure: Number of Participants With All Revascularization
timeFrame: 3 year post index procedure
measure: Number of Participants With All Revascularization
timeFrame: 4 year post index procedure
measure: Number of Participants Experienced Bleeding
timeFrame: 8 months post index procedure
measure: Number of Participants Experienced Bleeding
timeFrame: 1 year post index procedure
measure: Number of Participants Experienced Bleeding
timeFrame: 2 year post index procedure
measure: Number of Participants Experienced Bleeding
timeFrame: 3 year post index procedure
measure: Number of Participants Experienced Bleeding
timeFrame: 4 year post index procedure
measure: Percent Diameter Stenosis (%DS)
timeFrame: Baseline
measure: Percent Diameter Stenosis (%DS)
timeFrame: Post procedure
measure: Percent Diameter Stenosis (%DS)
timeFrame: 8 months post index procedure
measure: Acute Gain: In-stent, In-segment
timeFrame: 8 months post index procedure
measure: Net Gain: In-stent, In-segment
timeFrame: 8 months post index procedure
measure: Late Loss(LL): In-stent, In-segment, Proximal, and Distal
timeFrame: 8 months post index procedure
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Abbott Vascular Japan Co., Ltd.
Study officials:
affiliation: Teikyo University Hospital, Tokyo
name: Ken Kozuma, MD
role: STUDY_CHAIR
References: