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

Coronary Artery Disease Clinical Trial

— IRIS Skypoint  

Official title:

a Non-randomized, Prospective, Open-label Registry to Compare the Effectiveness and Safety of XIENCE Skypoint™ Stents Versus Other DESs in Patients With Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05981911
• Other study ID #: AMCCV2023-04
• Status: Recruiting
• Start date: December 30, 2023
• Est. completion date: February 2026

Study information

• Verified date: December 2023
• Source: Asan Medical Center
• Contact: Jung-hee Ham, Project manager
• Phone: 82230104728
• Email: cvcrc5[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: February 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• XIENCE Skypoint™ stent
Percutaneous coronary intervention with Xience-Skypoint™ stent

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)	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.	12 months
Secondary	the event rate of all cause death		5 years
Secondary	the event rate of cardiac death		5 years
Secondary	the event rate of nonfatal myocardial infarction		5 years
Secondary	the composite event rate of death, or nonfatal myocardial infarction (MI)		5 years
Secondary	the composite event rate of cardiac death, or nonfatal myocardial infarction (MI)		5 years
Secondary	the event rate of Target- Vessel Revascularization (TVR)		5 years
Secondary	the event rate of Target- lesion Revascularization (TLR)		5 years
Secondary	the event rate of stent thrombosis	according to an Academic Research Consortium (ARC) criteria	5 years
Secondary	the event rate of stroke		5 years
Secondary	the event rate of Procedural success	(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.	7 days