IRIS- DESyne X2 in the IRIS-DES Registry | NCT03588481

Studies
IRIS- DESyne X2 in the IRIS-DES Registry

NCT03588481

Sponsor

Seung-Jung Park

Status

Recruiting

Last Update Posted

Jun 24, 2026Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Coronary Stenosis
Coronary Occlusion
Coronary Disease

Interventions

DESyne X2

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

Jun 2026

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

Nov 28, 2018Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2031Estimated

First Submitted Date

Jul 5, 2018

First Submission Date that Met QC Criteria

Jul 5, 2018

First Posted Date

Jul 17, 2018Actual

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

Jun 23, 2026

Last Update Posted Date

Jun 24, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seung-Jung Park, Professor, Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, 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

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

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Coronary stenosis			Device: DESyne X2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DESyne X2	Device	Novolimus-eluting stent	Coronary stenosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite event rate	Death, non-fatal myocardial infarction, Target Vessel Revascularization	1year

Secondary Outcomes

Measure	Description	Time Frame
All death		5years
Cardiac death		5years
Myocardial infarction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 19 and more
Intervention with DeSyne X2 drug-eluting coronary stent
Agreed with written informed consent form

Exclusion Criteria:

Intervention with DeSyne X2 drug-eluting coronary stent and other drug eluting stent at the same time
Life expectancy of 1year and under
Cardiac 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 with DeSyne X2 stent

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

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

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hallym Hospital	Recruiting	Incheon			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
D023921	Coronary Stenosis
D054059	Coronary Occlusion
D003327	Coronary Disease

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided