DXR Stent(Previous Cilotax) Implantation Registry | NCT01612819

Studies
DXR Stent(Previous Cilotax) Implantation Registry

NCT01612819

Sponsor

Seung-Jung Park

Status

Terminated

Last Update Posted

Mar 31, 2017Actual

Enrollment

451Actual

Phase

Not provided

Conditions

Coronary Artery Diseases

Interventions

Not provided

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

Mar 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No more enrollment

Expanded Access Info

Start Date

Apr 2012Actual

Primary Completion Date

Mar 30, 2017Actual

Completion Date

Mar 30, 2017Actual

First Submitted Date

Jun 1, 2012

First Submission Date that Met QC Criteria

Jun 4, 2012

First Posted Date

Jun 6, 2012Estimated

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

Mar 30, 2017

Last Update Posted Date

Mar 31, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seung-Jung Park, MD, PhD, CardioVascular Research Foundation, KoreaSponsor-Investigator

Lead Sponsor

Seung-Jung ParkOTHER

Collaborators

Name	Class
CardioVascular Research Foundation, Korea	OTHER
Cardiotec Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Not provided

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

451Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)		at 12 months post procedure

Secondary Outcomes

Measure	Description	Time Frame
Death (all cause and cardiac)		one month
Death (all cause and cardiac)		6 months
Death (all cause and cardiac)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with significant coronary artery disease and receiving Cilotax (dual drug eluting stent)
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 presented with cardiogenic shock

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with coronary artery disease requiring drug eluting stents

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ki Bae Seung, MD, PhD	Seoul St. Mary's Hospital, Catholic University of Korea	Principal Investigator
Seung-Jung Park, MD, PhD	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Soonchunhyang University Hospital, Buchen		Bucheon-si			South Korea
Dankook University Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

This is not a publicly funded trial.

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