XIENCE PRIME Japan Post-Marketing Surveillance (PMS)

Abbott

Status: Completed

Conditions: Coronary Artery Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Occlusion; Angina

Treatments: Device: XIENCE PRIME - Long Length (LL); Device: XIENCE PRIME - Core Size

Study type: Observational

Funder types: Industry

Identifiers

NCT01721096

12-398

Details and patient eligibility

About

The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation.

Full description

The primary objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation by Pharmaceuticals and Medical Devices Agency (PMDA).

Enrollment: 536 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with ischemic heart disease who are eligible for treatment with XIENCE PRIME Everolimus Eluting Stent
• Patient provides Informed Consent Form

Exclusion criteria

• 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.

Trial design

536 participants in 2 patient groups

XIENCE PRIME - Long Length (LL)

Description:

Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length).There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted, and target lesion characteristics other than lesion lengths.

Treatment:

Device: XIENCE PRIME - Long Length (LL)

XIENCE PRIME - Core Size

Description:

Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted, and target lesion characteristics other than lesion lengths.

Treatment:

Device: XIENCE PRIME - Core Size