Evaluation of Effectiveness and Safety of Xience Skypoint Stents in Routine Clinical Practice (IRIS Skypoint)

Seung-Jung Park

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Device: XIENCE Skypoint™ stent

Study type: Observational

Funder types: Other

Identifiers

NCT05981911

AMCCV2023-04

Details and patient eligibility

About

The objective of this study is to evaluate the effectiveness and safety of XIENCE Skypoint stents in comparison to other drug-eluting stents (DES) in real-world practice.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients ≥ 19 years old
2. Patients receiving Xience-Skypoint™ stents.
3. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion criteria

1. Patients with a mixture of other DESs
2. Terminal illness with life expectancy <1 year
3. Patients with cardiogenic shock

Trial design

2,000 participants in 1 patient group

XIENCE Skypoint™ stent

Description:

Patients receiving Xience-Skypoint™ stents

Treatment:

Device: XIENCE Skypoint™ stent