Evaluation of Effectiveness and Safety of Xience Skypoint... | NCT05981911

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

NCT05981911

Sponsor

Seung-Jung Park

Status

Recruiting

Last Update Posted

Jan 2, 2026Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

XIENCE Skypoint™ stent

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 14, 2023Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Aug 1, 2023

First Submission Date that Met QC Criteria

Aug 1, 2023

First Posted Date

Aug 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2025

Last Update Posted Date

Jan 2, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seung-Jung Park, Professor, Department of Cardiology, University of Ulsan College of Medicine, Asan Medical CenterSponsor-Investigator

Lead Sponsor

Seung-Jung ParkOTHER

Collaborators

Name	Class
CardioVascular Research Foundation, Korea	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
XIENCE Skypoint™ stent		Patients receiving Xience-Skypoint™ stents	Device: XIENCE Skypoint™ stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
XIENCE Skypoint™ stent	Device	Percutaneous coronary intervention with Xience-Skypoint™ stent	XIENCE Skypoint™ stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
the event rate of all cause death		5 years
the event rate of cardiac death		5 years
the event rate of nonfatal myocardial infarction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients receiving Xience-Skypoint™ stents.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jung-hee Ham, Project manager	Contact	82230104728		cvcrc5@amc.seoul.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Hospital	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided