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

NCT05981911 | Recruiting

• 1 other identifier: AMCCV2023-04
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

drug eluting stent; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• the event rate of all cause death

  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 composite event rate of cardiac death, or nonfatal myocardial infarction (MI)

  5 years

Study Arms (1)

XIENCE Skypoint™ stent

Patients receiving Xience-Skypoint™ stents

Device: XIENCE Skypoint™ stent

Interventions

XIENCE Skypoint™ stent DEVICE

Percutaneous coronary intervention with Xience-Skypoint™ stent

XIENCE Skypoint™ stent

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving Xience-Skypoint™ stents.

You may qualify if:

• Patients ≥ 19 years old
• Patients receiving Xience-Skypoint™ stents.
• 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.

You may not qualify if:

• Patients with a mixture of other DESs
• Terminal illness with life expectancy \<1 year
• Patients with cardiogenic shock

Sponsors & Collaborators

• Seung-Jung Park: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (1)

Asan Medical Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Jung-hee Ham, Project manager

CONTACT

82230104728; cvcrc5@amc.seoul.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Cardiology, University of Ulsan College of Medicine

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 8, 2023
• Study Start: December 14, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

KR (1)