XIENCE PRIME SV Everolimus Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE PRIME SV Japan PMS)

NCT ID: NCT02513719

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 312 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-05-13
• Study Completion Date: 2019-09-30

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.

Conditions

Ischemic Heart Disease; Angina Pectoris; Coronary Artery Disease; Coronary Artery Occlusion; Myocardial Ischemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

XIENCE PRIME SV Everolimus Eluting Coronary Stent

Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent

XIENCE PRIME SV Everolimus Eluting Coronary Stent

Intervention Type: DEVICE

Patients receiving XIENCE PRIME SV Everolimus Eluting Stent

Interventions

XIENCE PRIME SV Everolimus Eluting Coronary Stent

Patients receiving XIENCE PRIME SV Everolimus Eluting Stent

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ken Kozuma, MD

Role: STUDY_CHAIR

Teikyo University Hospital, Tokyo

Locations

Kimitsu Chuo Hospital

Chiba, , Japan

Kokura Memorial Hospital

Fukuoka, , Japan

Fukuoka Wajiro Hospital

Fukuoka, , Japan

Hoshi general hospital

Fukushima, , Japan

Tsuchiya General Hospital

Hiroshima, , Japan

Hyogo Prefectural Amagasaki Hospital

Hyōgo, , Japan

Tsukuba Medical Center Hospital

Ibaraki, , Japan

Ishikawa Prefectual Central Hospital

Ishikawa, , Japan

Shonan Kamakura General Hospital

Kanagawa, , Japan

Tokai University Hospital

Kanagawa, , Japan

Kumamoto Chuo Hospital

Kumamoto, , Japan

Kyoto University Hospital

Kyoto, , Japan

Miyazaki City-Gun Ishikai Hospital

Miyazaki, , Japan

Kansai Rosai Hospital

Nagoya, , Japan

Nagoya Daini Red Cross Hospital

Nagoya, , Japan

Heart disease center Sakakibara hospital

Okayama, , Japan

Kurashiki Central Hospital

Okayama, , Japan

Sakurabashi Watanabe Hospital

Osaka, , Japan

Osaka police hospital

Osaka, , Japan

Osaka University Hospital

Osaka, , Japan

Tokorozawa Heart Center

Saitama, , Japan

Tokeidai memorial hospital

Sapporo, , Japan

JCHO Hokkaido Hospital

Sapporo, , Japan

Hokkaido Ohno hospital

Sapporo, , Japan

Sendai Kousei Hospital

Sendai, , Japan

Okamura memorial hospital

Shizuoka, , Japan

Tokushima Red Cross Hospital

Tokushima, , Japan

Mitsui Memorial Hospital

Tokyo, , Japan

Toranomon hospital

Tokyo, , Japan

Tokyo Women's Medical University Hospital

Tokyo, , Japan

Teikyo University Hospoital

Tokyo, , Japan

Showa University Fujigaoka hospital

Yokohama, , Japan

Saiseikai Yokohama City Tobu Hospital

Yokohama, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

12-303

Identifier Type: -

Identifier Source: org_study_id