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

NCT ID: NCT02513732

Last Updated: 2021-05-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2020-09-30

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.

Conditions

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

Study Design

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

Study Groups

XIENCE Xpedition 2.25 mm stent arm

Patients receiving XIENCE Xpedition 2.25 mm stent

XIENCE Xpedition 2.25 mm stent

Intervention Type: DEVICE

Patients receiving XIENCE Xpedition 2.25 mm stent

Interventions

XIENCE Xpedition 2.25 mm stent

Patients receiving XIENCE Xpedition 2.25 mm stent

Intervention Type: DEVICE

Eligibility Criteria

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.

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.

• 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

Hyogo Prefectural Amagasaki Hospital

Hyōgo, , Japan

Ishikawa Prefectural Central Hospital

Ishikawa, , Japan

Miyazaki Medical Association Hospital

Miyazaki, , Japan

Osaka Police Hospital

Osaka, , Japan

Hanaoka Seishu Memorial Cardiovascular Clinic

Sapporo, , Japan

JCHO Hokkaido Hospital

Sapporo, , Japan

Tokushima Red Cross Hospital

Tokushima, , Japan

Mitsui Memorial Hospital

Tokyo, , Japan

Toranomon Hospital

Tokyo, , Japan

Teikyo University Hospital

Tokyo, , Japan

Showa University Fujigaoka Hospital

Yokohama, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

14-306

Identifier Type: -

Identifier Source: org_study_id