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

NCT02513732 | Completed Results DMC

• 1 other identifier: 14-306
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 11

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.

Conditions

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

Keywords

Drug Eluting Stent; Coronary Stent; Everolimus; Stent Thrombosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Stent Thrombosis: Late

  Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation

  30 days to 1 year post stent implantation-Day 212

Secondary Outcomes (126)

• Percent Diameter Stenosis (%DS)

  Pre-procedure

• Percent Diameter Stenosis (%DS)

  Immediately after the procedure

• Percent Diameter Stenosis (%DS)

  During follow-up, at 8 months post procedure

• Number of Participants Using Antiplatelet Therapy

  At baseline before procedure

• Number of Participants Using Antiplatelet Therapy

  Date of discharge from procedure day

Study Arms (1)

XIENCE Xpedition 2.25 mm stent arm

Patients receiving XIENCE Xpedition 2.25 mm stent

Device: XIENCE Xpedition 2.25 mm stent

Interventions

XIENCE Xpedition 2.25 mm stent DEVICE

Patients receiving XIENCE Xpedition 2.25 mm stent

XIENCE Xpedition 2.25 mm stent arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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 attending or will attend other PMS with invasive medical procedure will not be registered.
• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (11)

Hyogo Prefectural Amagasaki Hospital

Hyōgo, 660-0828, Japan

Location

Ishikawa Prefectural Central Hospital

Ishikawa, 920-8530, Japan

Location

Miyazaki Medical Association Hospital

Miyazaki, 880-0834, Japan

Location

Osaka Police Hospital

Osaka, 543-0035, Japan

Location

Hanaoka Seishu Memorial Cardiovascular Clinic

Sapporo, 062-0003, Japan

Location

JCHO Hokkaido Hospital

Sapporo, 062-8618, Japan

Location

Tokushima Red Cross Hospital

Tokushima, 773-8502, Japan

Location

Mitsui Memorial Hospital

Tokyo, 101-8643, Japan

Location

Toranomon Hospital

Tokyo, 105-8470, Japan

Location

Teikyo University Hospital

Tokyo, 173-8606, Japan

Location

Showa University Fujigaoka Hospital

Yokohama, 227-8501, Japan

Location

MeSH Terms

Conditions

Myocardial Ischemia; Angina Pectoris; Coronary Artery Disease

Interventions

Stents

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Results Point of Contact

• Title: Hajime Kusano, Senior Adviser Clinical
• Organization: Abbott

hajime.kusano@abbott.com

+1 4088451626

Study Officials

• Ken Kozuma, MD

  Teikyo University Hospital, Tokyo

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: August 3, 2015
• Study Start: July 1, 2014
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: May 13, 2021
• Results First Posted: February 21, 2019

Record last verified: 2021-04

Locations

JP (11)