NCT01721096

XIENCE PRIME Japan Post-Marketing Surveillance (PMS)

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 536 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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).

Conditions

• Angina
• Coronary Occlusion
• Coronary Artery Disease
• Coronary Artery Stenosis
• Myocardial Ischemia

Interventions

Type	Name	Description
DEVICE	XIENCE PRIME - Long Length (LL)	Long Length
DEVICE	XIENCE PRIME - Core Size	Core Size

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-06-01
• Completion: 2018-11-01
• First posted: 2012-11-05
• Last updated: 2019-12-20
• Results posted: 2016-07-19

Locations

1 site across 1 country: Japan