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

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Device: XIENCE Skypoint™ stent

• Registration Number: NCT05981911
• Lead Sponsor: Seung-Jung Park

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-01
• Study First Submitted QC: 2023-08-01
• Study First Posted: 2023-08-08
• Study Start: 2023-12-14
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26
• Primary Completion: 2025-09
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
XIENCE Skypoint™ stent	XIENCE Skypoint™ stent	Patients receiving Xience-Skypoint™ stents

Primary Outcome Measures

Name	Time	Method
the composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)	12 months	the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) at 12 months post procedure.; A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.

Secondary Outcome Measures

Name	Time	Method
the event rate of Target- lesion Revascularization (TLR)	5 years
the event rate of all cause death	5 years
the composite event rate of cardiac death, or nonfatal myocardial infarction (MI)	5 years
the event rate of cardiac death	5 years
the event rate of nonfatal myocardial infarction	5 years
the composite event rate of death, or nonfatal myocardial infarction (MI)	5 years
the event rate of Target- Vessel Revascularization (TVR)	5 years
the event rate of stent thrombosis	5 years	according to an Academic Research Consortium (ARC) criteria
the event rate of stroke	5 years
the event rate of Procedural success	7 days	(defined as achievement of a final diameter stenosis of \<30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization.

Trial Locations

Locations (1)

Asan Medical Hospital; 🇰🇷 Seoul, Korea, Republic of