Clinical trial NCT02513732: XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE Xpedition SV Japan PMS)
Official title: XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Keywords: Drug Eluting Stent
Coronary Stent
Everolimus
Stent Thrombosis
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-08-03
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General patient population with ischemic heart disease in Japan who are eligible for treatment with XIENCE Xpedition 2.25 mm stent will be included in the study.

Brief summary: The objective of the study is to evaluate the safety and efficacy of XIENCE Xpedition Everolimus-Eluting 2.25mm Stent 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 Xpedition Everolimus-Eluting 2.25mm 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.

The XIENCE Xpedition 2.25 mm stent is composed of the stent identical to the stent of the XIENCE PRIME SV Stent.Therefore, the data collected from the PMS will be pooled with data collected from the ongoing XIENCE PRIME SV PMS for analysis.

Eligibility criteria: 1. Inclusion criteria

   1. 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.
   2. Patients who are treated by XIENCE Xpedition 2.25mm stent will be registered.

      * The observations will be compiled on a per-patient basis even if multiple XIENCE Xpedition 2.25mm stents are implanted during the index procedure.
      * A patient whose side-branch is treated by XIENCE Xpedition 2.25mm stent can be registered. In such a case, main vessel should be treated by XIENCE Xpedition.
      * The observations will not be compiled on a per-patient basis if a patient is treated by XIENCE Xpedition 2.25mm stent overlapped with other stents for bail-out purpose.
      * 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 Xpedition 2.25mm stent and finally treated by other devices only (No XIENCE Xpedition 2.25mm stent are implanted) must also be registered. In such a case, only the stent information, device deficiency information and reportable adverse events related to the Xpedition stent, if any, are required to be captured. Follow-up of the patient who does not receive any XIENCE Xpedition 2.25mm stent is not required.
2. Exclusion criteria

   1. 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.
   2. Patients who are attending or will attend other PMS with invasive medical procedure will not be registered.
3. A patient may have another lesion(s) that may be treated by larger diameter (≥ 2.5mm) stent(s). In such a case, treatment by XIENCE Xpedition is preferable. Lesion(s) treated by other than XIENCE Xpedition 2.25mm stent is not considered as the target lesion.

Primary outcomes:
measure: Number of Participants With Stent Thrombosis: Late
timeFrame: 30 days to 1 year post stent implantation-Day 212
Secondary outcomes:
measure: Percent Diameter Stenosis (%DS)
timeFrame: Pre-procedure
measure: Percent Diameter Stenosis (%DS)
timeFrame: Immediately after the procedure
measure: Percent Diameter Stenosis (%DS)
timeFrame: During follow-up, at 8 months post procedure
measure: Number of Participants Using Antiplatelet Therapy
timeFrame: At baseline before procedure
measure: Number of Participants Using Antiplatelet Therapy
timeFrame: Date of discharge from procedure day
measure: Number of Participants Using Antiplatelet Therapy
timeFrame: 8 months observation day from the procedure day
measure: Number of Participants Using Antiplatelet Therapy
timeFrame: 1 year observation day from the procedure day
measure: Number of Participants Using Antiplatelet Therapy
timeFrame: 2 years observation day from the procedure day
measure: Number of Participants Using Antiplatelet Therapy
timeFrame: 3 years observation day from the procedure day
measure: Number of Participants Using Antiplatelet Therapy
timeFrame: 4 years observation day from the procedure day
measure: Number of Participants Using Antiplatelet Therapy
timeFrame: 5 years observation day from the procedure day
measure: Number of Participants With Death
timeFrame: During hospitalization
measure: Number of Participants With Death
timeFrame: 0 to 8 months
measure: Number of Participants With Death
timeFrame: 0 to 1 year
measure: Number of Participants With Death
timeFrame: 0 to 2 years
measure: Number of Participants With Death
timeFrame: 0 to 3 years
measure: Number of Participants With Death
timeFrame: 0 to 4 years
measure: Number of Participants With Death
timeFrame: 0 to 5 years
measure: Number of Participants With Target Lesion Revascularization Based on Ischemia Findings
timeFrame: During hospitalization
measure: Number of Participants With Target Lesion Revascularization Based on Ischemia Findings
timeFrame: 0 to 8 months
measure: Number of Participants With Target Lesion Revascularization Based on Ischemia Findings
timeFrame: 0 to 1 year
measure: Number of Participants With Target Lesion Revascularization Based on Ischemia Findings
timeFrame: 0 to 2 years
measure: Number of Participants With Target Lesion Revascularization Based on Ischemia Findings
timeFrame: 0 to 3 years
measure: Number of Participants With Target Lesion Revascularization Based on Ischemia Findings
timeFrame: 0 to 4 years
measure: Number of Participants With Target Lesion Revascularization Based on Ischemia Findings
timeFrame: 0 to 5 years
measure: Number of Participants With Myocardial Infarction
timeFrame: During hospitalization
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 to 3 years
measure: Number of Participants With Myocardial Infarction
timeFrame: 0 to 4 years
measure: Number of Participants With Myocardial Infarction
timeFrame: 0 to 5 years
measure: Number of Participants With Cardiac Death
timeFrame: During hospitalization
measure: Number of Participants With Cardiac Death
timeFrame: 0 to 8 months
measure: Number of Participants With Cardiac Death
timeFrame: 0 to 1 year
measure: Number of Participants With Cardiac Death
timeFrame: 0 to 2 years
measure: Number of Participants With Cardiac Death
timeFrame: 0 to 3 Years
measure: Number of Participants With Cardiac Death
timeFrame: 0 to 4 years
measure: Number of Participants With Cardiac Death
timeFrame: 0 to 5 years
measure: Number of Participants With MI Related to Target Vessel
timeFrame: During hospitalization
measure: Number of Participants With MI Related to Target Vessel
timeFrame: 0 to 8 months
measure: Number of Participants With MI Related to Target Vessel
timeFrame: 0 to 1 year
measure: Number of Participants With MI Related to Target Vessel
timeFrame: 0 to 2 years
measure: Number of Participants With MI Related to Target Vessel
timeFrame: 0 to 3 years
measure: Number of Participants With MI Related to Target Vessel
timeFrame: 0 to 4 years
measure: Number of Participants With MI Related to Target Vessel
timeFrame: 0 to 5 years
measure: Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)
timeFrame: During hospitalization
measure: Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)
timeFrame: 0 to 8 months
measure: Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)
timeFrame: 0 to 1 year
measure: Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)
timeFrame: 0 to 2 years
measure: Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)
timeFrame: 0 to 3 years
measure: Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)
timeFrame: 0 to 4 years
measure: Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)
timeFrame: 0 to 5 years
measure: Number of Participants With All Revascularization
timeFrame: During hospitalization
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 Target Vessel Failure (TVF)
timeFrame: During hospitalization
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 0 to 8 months
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 0 to 1 year
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 0 to 2 years
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 0 to 3 years
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 0 to 4 years
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 0 to 5 years
measure: Number of Participants With Target Vessel Revascularization (Non-TLR)
timeFrame: During hospitalization
measure: Number of Participants With Target Vessel Revascularization (Non-TLR)
timeFrame: 0 to 8 months
measure: Number of Participants With Target Vessel Revascularization (Non-TLR)
timeFrame: 0 to 1 year
measure: Number of Participants With Target Vessel Revascularization (Non-TLR)
timeFrame: 0 to 2 years
measure: Number of Participants With Target Vessel Revascularization (Non-TLR)
timeFrame: 0 to 3 years
measure: Number of Participants With Target Vessel Revascularization (Non-TLR)
timeFrame: 0 to 4 years
measure: Number of Participants With Target Vessel Revascularization (Non-TLR)
timeFrame: 0 to 5 years
measure: Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))
timeFrame: During hospitalization
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 to 3 years
measure: Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))
timeFrame: 0 to 4 years
measure: Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))
timeFrame: 0 to 5 years
measure: Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
timeFrame: During hospitalization
measure: Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
timeFrame: 0 to 8 months
measure: Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
timeFrame: 0 to 1 year
measure: Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
timeFrame: 0 to 2 years
measure: Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
timeFrame: 0 to 3 years
measure: Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
timeFrame: 0 to 4 years
measure: Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
timeFrame: 0 to 5 years
measure: Number of Participants With Death/All MI
timeFrame: During hospitalization
measure: Number of Participants With Death/All MI
timeFrame: 0 to 8 months
measure: Number of Participants With Death/All MI
timeFrame: 0 to 1 year
measure: Number of Participants With Death/All MI
timeFrame: 0 to 2 years
measure: Number of Participants With Death/All MI
timeFrame: 0 to 3 years
measure: Number of Participants With Death/All MI
timeFrame: 0 to 4 years
measure: Number of Participants With Death/All MI
timeFrame: 0 to 5 years
measure: Number of Participants With Cardiac Death/All MI
timeFrame: During hospitalization
measure: Number of Participants With Cardiac Death/All MI
timeFrame: 0 to 8 months
measure: Number of Participants With Cardiac Death/All MI
timeFrame: 0 to 1 year
measure: Number of Participants With Cardiac Death/All MI
timeFrame: 0 to 2 years
measure: Number of Participants With Cardiac Death/All MI
timeFrame: 0 to 3 years
measure: Number of Participants With Cardiac Death/All MI
timeFrame: 0 to 4 years
measure: Number of Participants With Cardiac Death/All MI
timeFrame: 0 to 5 years
measure: Number of Participants With Cardiac Death or Target-Vessel MI
timeFrame: During hospitalization
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: Number of Participants With Target Lesion Failure (TLF)
timeFrame: During hospitalization
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 0 to 8 months
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 0 to 1 year
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 0 to 2 years
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 0 to 3 years
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 0 to 4 years
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 0 to 5 years
measure: Mean Acute Gain: In-stent, In-segment
timeFrame: At 8 months, post index procedure
measure: Mean Late Loss(LL): In-stent, In-segment, Proximal, and Distal
timeFrame: At 8 months, post index procedure
measure: Mean Net Gain: In-stent, In-segment
timeFrame: At 8 months, post index procedure
measure: Mean Lesion Length
timeFrame: Pre-procedure
measure: Minimum Blood Vessel Diameter
timeFrame: Pre-procedure
measure: Minimum Blood Vessel Diameter
timeFrame: Immediately after the procedure
measure: Minimum Blood Vessel Diameter
timeFrame: During follow-up, at 8 months post procedure
measure: Mean Reference Vessel Diameter (RVD)
timeFrame: Pre-procedure
measure: Mean Reference Vessel Diameter (RVD)
timeFrame: Immediately after the procedure
measure: Mean Reference Vessel Diameter (RVD)
timeFrame: During follow-up, at 8 months post procedure
Other outcomes:
Locations:
city: Hyogo
country: Japan
facility: Hyogo Prefectural Amagasaki Hospital
city: Ishikawa
country: Japan
facility: Ishikawa Prefectural Central Hospital
city: Miyazaki
country: Japan
facility: Miyazaki Medical Association Hospital
city: Osaka
country: Japan
facility: Osaka Police Hospital
city: Sapporo
country: Japan
facility: Hanaoka Seishu Memorial Cardiovascular Clinic
city: Sapporo
country: Japan
facility: JCHO Hokkaido 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: Teikyo University Hospital
city: Yokohama
country: Japan
facility: Showa University Fujigaoka Hospital
Study officials:
affiliation: Teikyo University Hospital, Tokyo
name: Ken Kozuma, MD
role: STUDY_CHAIR
References: