Clinical trial NCT02513719: XIENCE PRIME SV Everolimus Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE PRIME SV Japan PMS)
Official title: XIENCE PRIME SV Everolimus Eluting Coronary Stent Japan Post Marketing Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Angina Pectoris
Coronary Artery Disease
Coronary Artery Occlusion
Myocardial Ischemia
Keywords: drug eluting stent
stent
real world
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-08-03
Enrollment: 312
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General patient population with ischemic heart disease in Japan who are eligible for treatment with XIENCE PRIME SV Everolimus Eluting Stent will be included in the study.

Brief summary: The objective of the study is to evaluate the safety and efficacy of XIENCE PRIME SV in real world practice in Japanese hospitals.

Detailed description: Based on Good Post-marketing Study Practice (GPSP) regulation, general patient population with ischemic heart disease who are eligible for treatment with XIENCE PRIME SV Everolimus Eluting Stent will be registered, with no particular inclusion/exclusion criteria, and may be eligible for angiographic follow-up at eight months and clinical follow-up at one year.

Eligibility criteria: * Patient informed consent is required for registration of this PMS. In cases where patient informed consent (or providing some type of information) is required for PMS per the participating site policy, the Sponsor will cooperate as needed.
* 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.
* Patients who are treated (stent delivery system inserted into the body) by XIENCE PRIME SV will be registered (including provisional stenting for side branch treatment but excluding bail-out only use).

  * The observations will be compiled on a per-patient basis even if multiple stents are implanted during the index procedure.
  * A patient whose side-branch is treated by XIENCE PRIME SV can be registered. In such a case, main vessel should be treated by XIENCE PRIME.
  * A patient who are treated by other drug eluting stent (DES) for planned stent and XIENCE PRIME SV for bail-out purpose cannot be registered.
  * Additional revascularization procedures as a part of adverse event treatment and planned staged procedures will not be considered as another registration, or adverse events.
  * A patient who is treated, but failed to be implanted by XIENCE PRIME SV and finally treated by other devices only (No XIENCE PRIME SV are implanted) must also be registered. In such a case, only the stent information, device deficiency information and reportable adverse events related to the PRIME stent, if any, are required to be captured. Follow-up of the patient who does not receive any XIENCE PRIME SV stent is not required.
* A patient may have another lesion(s) that may be treated by larger diameter stent(s). In such a case, treatment by XIENCE PRIME is preferable. Lesion(s) treated by other than XIENCE PRIME is not considered as the target lesion.

Primary outcomes:
measure: Number of Participants With Stent Thrombosis: Acute
timeFrame: 0-24 hours post stent implantation
measure: Number of Participants With Stent Thrombosis: Subacute
timeFrame: >24 hours to 30 days post stent implantation
measure: Number of Participants With Stent Thrombosis: Late
timeFrame: 30 days to 1 year post stent implantation
Secondary outcomes:
measure: Number of Participants With Stent Thrombosis: Very Late
timeFrame: >1 year post stent implantation
measure: Percent Diameter Stenosis (%DS)
timeFrame: Pre-procedure
measure: Percent Diameter Stenosis (%DS)
timeFrame: post procedure (on day 0)
measure: Percent Diameter Stenosis (%DS)
timeFrame: 8 months
measure: Success Rate: Percentage of Devices With Implant Success
timeFrame: < or = 1 day
measure: Success Rate: Percentage of Lesions With Procedural Success
timeFrame: < or = 1 day
measure: Success Rate: XIENCE PRIME Implant Success by Patient
timeFrame: < or = 1 day
measure: Number of Death
timeFrame: 0 to 8 months
measure: Number of Death
timeFrame: 0 to 1 year
measure: Number of Death
timeFrame: 0 to 2 years
measure: Number of Death
timeFrame: 0-3 years
measure: Number of Death
timeFrame: 0-4 years
measure: Number of Death
timeFrame: 0-５ years
measure: Number of Participants With Myocardial Infarction
timeFrame: 0 to 8 months
measure: Number of Participants With Myocardial Infarction
timeFrame: 0 to 1 year
measure: Number of Participants With Myocardial Infarction
timeFrame: 0 to 2 years
measure: Number of Participants With Myocardial Infarction
timeFrame: 0-3 years
measure: Number of Participants With Myocardial Infarction
timeFrame: 0-4 years
measure: Number of Participants With Myocardial Infarction
timeFrame: 0-5 years
measure: Number of Participants With Target Lesion Revascularization
timeFrame: 0 to 8 months
measure: Number of Participants With Target Lesion Revascularization
timeFrame: 0 to 1 year
measure: Number of Participants With Target Lesion Revascularization
timeFrame: 0 to 2 years
measure: Number of Participants With Target Lesion Revascularization
timeFrame: 0-3 years
measure: Number of Participants With Target Lesion Revascularization
timeFrame: 0-4 years
measure: Number of Participants With Target Lesion Revascularization
timeFrame: 0-5 years
measure: Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)
timeFrame: 0 to 8 months
measure: Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)
timeFrame: 0 to 1 year
measure: Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)
timeFrame: 0 to 2 years
measure: Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)
timeFrame: 0-3 years
measure: Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)
timeFrame: 0-4 years
measure: Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)
timeFrame: 0-5 years
measure: Number of Participants With Non-target Vessel Revascularization (Non-TVR)
timeFrame: 0 to 8 months
measure: Number of Participants With Non-target Vessel Revascularization (Non-TVR)
timeFrame: 0 to 1 year
measure: Number of Participants With Non-target Vessel Revascularization (Non-TVR)
timeFrame: 0 to 2 years
measure: Number of Participants With Non-target Vessel Revascularization (Non-TVR)
timeFrame: 0 to 3 years
measure: Number of Participants With Non-target Vessel Revascularization (Non-TVR)
timeFrame: 0 to 4 years
measure: Number of Participants With Non-target Vessel Revascularization (Non-TVR)
timeFrame: 0 to 5 years
measure: Number of Participants With All Revascularization
timeFrame: 0 to 8 months
measure: Number of Participants With All Revascularization
timeFrame: 0 to 1 year
measure: Number of Participants With All Revascularization
timeFrame: 0 to 2 years
measure: Number of Participants With All Revascularization
timeFrame: 0 to 3 years
measure: Number of Participants With All Revascularization
timeFrame: 0 to 4 years
measure: Number of Participants With All Revascularization
timeFrame: 0 to 5 years
measure: Number of Participants With Hemorrhage
timeFrame: 0 to 8 months
measure: Number of Participants With Hemorrhage
timeFrame: 0 to 1 year
measure: Number of Participants With Hemorrhage
timeFrame: 0 to 2 years
measure: Number of Participants With Hemorrhage
timeFrame: 0 to 3 years
measure: Number of Participants With Hemorrhage
timeFrame: 0 to 4 years
measure: Number of Participants With Hemorrhage
timeFrame: 0 to 5 years
measure: Number of Participants With Target Lesion Failure
timeFrame: 0 to 8 months
measure: Number of Participants With Target Lesion Failure
timeFrame: 0 to 1 year
measure: Number of Participants With Target Lesion Failure
timeFrame: 0 to 2 years
measure: Number of Participants With Target Lesion Failure
timeFrame: 0 to 3 years
measure: Number of Participants With Target Lesion Failure
timeFrame: 0 to 4 years
measure: Number of Participants With Target Lesion Failure
timeFrame: 0 to 5 years
measure: Number of Participants With All Death/All MI/All Revascularization
timeFrame: 0 to 8 months
measure: Number of Participants With All Death/All MI/All Revascularization
timeFrame: 0 to 1 year
measure: Number of Participants With All Death/All MI/All Revascularization
timeFrame: 0 to 2 years
measure: Number of Participants With All Death/All MI/All Revascularization
timeFrame: 0 to 3 years
measure: Number of Participants With All Death/All MI/All Revascularization
timeFrame: 0 to 4 years
measure: Number of Participants With All Death/All MI/All Revascularization
timeFrame: 0 to 5 years
measure: Number of Participants With Target Vessel Failure
timeFrame: 0 to 8 months
measure: Number of Participants With Target Vessel Failure
timeFrame: 0 to 1 year
measure: Number of Participants With Target Vessel Failure
timeFrame: 0 to 2 years
measure: Number of Participants With Target Vessel Failure
timeFrame: 0 to 3 years
measure: Number of Participants With Target Vessel Failure
timeFrame: 0 to 4 years
measure: Number of Participants With Target Vessel Failure
timeFrame: 0 to 5 years
measure: Number of Participants With Major Adverse Cardiac Events (MACE)
timeFrame: 0 to 8 months
measure: Number of Participants With Major Adverse Cardiac Events (MACE)
timeFrame: 0 to 1 year
measure: Number of Participants With Major Adverse Cardiac Events (MACE)
timeFrame: 0 to 2 years
measure: Number of Participants With Major Adverse Cardiac Events (MACE)
timeFrame: 0 to 3 years
measure: Number of Participants With Major Adverse Cardiac Events (MACE)
timeFrame: 0 to 4 years
measure: Number of Participants With Major Adverse Cardiac Events (MACE)
timeFrame: 0 to 5 years
measure: Number of Participants With Death or MI
timeFrame: 0 to 8 months
measure: Number of Participants With Death or MI
timeFrame: 0 to 1 year
measure: Number of Participants With Death or MI
timeFrame: 0 to 2 years
measure: Number of Participants With Death or MI
timeFrame: 0 to 3 years
measure: Number of Participants With Death or MI
timeFrame: 0 to 4 years
measure: Number of Participants With Death or MI
timeFrame: 0 to 5 years
measure: Number of Participants With Cardiac Death or MI
timeFrame: 0 to 8 months
measure: Number of Participants With Cardiac Death or MI
timeFrame: 0 to 1 year
measure: Number of Participants With Cardiac Death or MI
timeFrame: 0 to 2 years
measure: Number of Participants With Cardiac Death or MI
timeFrame: 0 to 3 years
measure: Number of Participants With Cardiac Death or MI
timeFrame: 0 to 4 years
measure: Number of Participants With Cardiac Death or MI
timeFrame: 0 to 5 years
measure: Number of Participants With Cardiac Death or Target-Vessel MI
timeFrame: 0 to 8 months
measure: Number of Participants With Cardiac Death or Target Vessel-MI
timeFrame: 0 to 1 year
measure: Number of Participants With Cardiac Death or Target Vessel MI
timeFrame: 0 to 2 years
measure: Number of Participants With Cardiac Death or Target Vessel MI
timeFrame: 0 to 3 years
measure: Number of Participants With Cardiac Death or Target Vessel MI
timeFrame: 0 to 4 years
measure: Number of Participants With Cardiac Death or Target Vessel MI
timeFrame: 0 to 5 years
measure: Acute Gain: In-stent,In-segment
timeFrame: Pre procedure to post procedure (on day 0)
measure: Late Loss(LL): In-stent,In-segment,Proximal, and Distal
timeFrame: 8 months
measure: Net Gain: In-stent, In-segment
timeFrame: Post-Procedure (on day 0)
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Kimitsu Chuo Hospital
city: Fukuoka
country: Japan
facility: Kokura Memorial Hospital
city: Fukuoka
country: Japan
facility: Fukuoka Wajiro Hospital
city: Fukushima
country: Japan
facility: Hoshi general hospital
city: Hiroshima
country: Japan
facility: Tsuchiya General Hospital
city: Hyogo
country: Japan
facility: Hyogo Prefectural Amagasaki Hospital
city: Ibaraki
country: Japan
facility: Tsukuba Medical Center Hospital
city: Ishikawa
country: Japan
facility: Ishikawa Prefectual Central Hospital
city: Kanagawa
country: Japan
facility: Shonan Kamakura General Hospital
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Kumamoto
country: Japan
facility: Kumamoto Chuo Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Miyazaki
country: Japan
facility: Miyazaki City-Gun Ishikai Hospital
city: Nagoya
country: Japan
facility: Kansai Rosai Hospital
city: Nagoya
country: Japan
facility: Nagoya Daini Red Cross Hospital
city: Okayama
country: Japan
facility: Heart disease center Sakakibara hospital
city: Okayama
country: Japan
facility: Kurashiki Central Hospital
city: Osaka
country: Japan
facility: Sakurabashi Watanabe Hospital
city: Osaka
country: Japan
facility: Osaka police hospital
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Saitama
country: Japan
facility: Tokorozawa Heart Center
city: Sapporo
country: Japan
facility: Tokeidai memorial hospital
city: Sapporo
country: Japan
facility: JCHO Hokkaido Hospital
city: Sapporo
country: Japan
facility: Hokkaido Ohno hospital
city: Sendai
country: Japan
facility: Sendai Kousei Hospital
city: Shizuoka
country: Japan
facility: Okamura memorial hospital
city: Tokushima
country: Japan
facility: Tokushima Red Cross Hospital
city: Tokyo
country: Japan
facility: Mitsui Memorial Hospital
city: Tokyo
country: Japan
facility: Toranomon hospital
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Hospital
city: Tokyo
country: Japan
facility: Teikyo University Hospoital
city: Yokohama
country: Japan
facility: Showa University Fujigaoka hospital
city: Yokohama
country: Japan
facility: Saiseikai Yokohama City Tobu Hospital
Study officials:
affiliation: Teikyo University Hospital, Tokyo
name: Ken Kozuma, MD
role: STUDY_CHAIR
References: