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

• Sponsor: Seung-Jung Park (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05981911
• Collaborator: CardioVascular Research Foundation, Korea (Other)
• Enrollment: 2,000
• Location: 1
• Anticipated Duration (Months): 29
• Patients Per Site Per Month: 68.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: XIENCE Skypoint™ stent

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2025
• Anticipated Study Completion Date: Feb 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
XIENCE Skypoint™ stent Patients receiving Xience-Skypoint™ stents	Device: XIENCE Skypoint™ stent; Percutaneous coronary intervention with Xience-Skypoint™ stent

Outcome Measures

Primary Outcome Measures

1. 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

1. the event rate of all cause death [5 years]

2. the event rate of cardiac death [5 years]

3. the event rate of nonfatal myocardial infarction [5 years]

4. the composite event rate of death, or nonfatal myocardial infarction (MI) [5 years]

5. the composite event rate of cardiac death, or nonfatal myocardial infarction (MI) [5 years]

6. the event rate of Target- Vessel Revascularization (TVR) [5 years]

7. the event rate of Target- lesion Revascularization (TLR) [5 years]

8. the event rate of stent thrombosis [5 years]

   according to an Academic Research Consortium (ARC) criteria

9. the event rate of stroke [5 years]

10. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seung-Jung Park
• CardioVascular Research Foundation, Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seung-Jung Park, Professor, Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT05981911
• Other Study ID Numbers: AMCCV2023-04
• First Posted: Aug 8, 2023
• Last Update Posted: Aug 8, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Seung-Jung Park, Professor, Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center: drug eluting stent; Percutaneous Coronary Intervention
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Study Results

No Results Posted as of Aug 8, 2023