Overview

This trial is active, not recruiting.

Conditions ischemic heart disease, angina pectoris, coronary artery disease, coronary artery occlusion, myocardial ischemia
Treatment xience prime sv everolimus eluting coronary stent
Phase phase 4
Sponsor Abbott Vascular
Start date March 2013
End date March 2015
Trial size 300 participants
Trial identifier NCT02513719, 12-303

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent
xience prime sv everolimus eluting coronary stent
Patients receiving XIENCE PRIME SV Everolimus Eluting Stent

Primary Outcomes

Measure
Stent Thrombosis: acute
time frame: 0-24 hours post stent implantation
Stent Thrombosis: subacute
time frame: >24 hours to 30 days post stent implantation
Stent Thrombosis: late
time frame: 30 days to 1 year post stent implantation
Stent thrombosis: very late
time frame: >1 year post stent implantation

Secondary Outcomes

Measure
Percent Diameter Stenosis (%DS)
time frame: At baseline before procedure
Percent Diameter Stenosis (%DS)
time frame: Participants will be followed post procedure through discharge, an expected duration of 1 week
Percent Diameter Stenosis (%DS)
time frame: 8 months
Thrombolysis In Myocardial Infarction (TIMI) Flow
time frame: At baseline before procedure
TIMI Flow
time frame: Participants will be followed post procedure through discharge, an expected duration of 1 week
TIMI Flow
time frame: 8 months
Percentage of participants using antiplatelet therapy
time frame: At baseline before procedure
Percentage of participants using maintenance antiplatelet therapy
time frame: Participants will be followed post procedure through discharge, an expected duration of 1 week
Percentage of participants changing or terminating antiplatelet therapy
time frame: 8 months
Percentage of participants changing or terminating antiplatelet therapy
time frame: 1 year
Percentage of participants changing or terminating antiplatelet therapy
time frame: 2 years
Percentage of participants changing or terminating antiplatelet therapy
time frame: 3 years
Percentage of participants changing or terminating antiplatelet therapy
time frame: 4 years
Percentage of participants changing or terminating antiplatelet therapy
time frame: 5 years
Death
time frame: 8 months
Death
time frame: 1 year
Death
time frame: 2 years
Death
time frame: 3 years
Myocardial infarction
time frame: 8 months
Myocardial infarction
time frame: 1 year
Myocardial infarction
time frame: 2 years
Myocardial infarction
time frame: 3 years
Target lesion revascularization
time frame: 8 months
Target lesion revascularization
time frame: 1 year
Target lesion revascularization
time frame: 2 years
Target lesion revascularization
time frame: 3 years
Target vessel revascularization
time frame: 8 months
Target vessel revascularization
time frame: 1 year
Target vessel revascularization
time frame: 2 years
Target vessel revascularization
time frame: 3 years

Eligibility Criteria

Male or female participants at least 20 years old.

- 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.

Additional Information

Official title XIENCE PRIME SV Everolimus Eluting Coronary Stent Post Marketing Surveillance
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Abbott Vascular.