The Usefulness of Coronary CT Scan After Everolimus-eluti... | NCT02981134

Studies
The Usefulness of Coronary CT Scan After Everolimus-eluting Bioabsorbable Scaffold Implantation for Coronary Artery Disease

NCT02981134

Sponsor

Jung-min Ahn

Status

Withdrawn

Last Update Posted

Jul 23, 2021Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Coronary Disease

Interventions

Computed tomographic scan

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

Jul 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study will be revived with retrospective design.

Expanded Access Info

Start Date

Dec 2021Estimated

Primary Completion Date

Jun 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Nov 30, 2016

First Submission Date that Met QC Criteria

Nov 30, 2016

First Posted Date

Dec 5, 2016Estimated

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

Jul 19, 2021

Last Update Posted Date

Jul 23, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jung-min Ahn, Assistant professor, Department of Cardiology, Heart Institute, University of Ulsan College of Medicine, Asan Medical CenterSponsor-Investigator

Lead Sponsor

Jung-min AhnOTHER

Collaborators

Name	Class
CardioVascular Research Foundation, Korea	OTHER

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

Description Module

Brief Summary

The purpose of this study is to evaluate usefulness of coronary computed tomographic scan for prediction of clinical events after everolimus-eluting bioabsorbable scaffold implantation for coronary artery disease.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bioabsorbable scaffold		Patients with BVS(bioabsorbable scaffold) for coronary stenosis	Procedure: Computed tomographic scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Computed tomographic scan	Procedure	after 1year of BVS implantation, computed tomographic scan will be performed	bioabsorbable scaffold

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Computed tomographic scan parameters	Computed tomographic scan parameters predicting clinical outcomes	3 years

Secondary Outcomes

Measure	Description	Time Frame
Restenosis	Restenosis on computed tomographic scan	1 year
Thrombosis	Thrombosis on computed tomographic scan	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients treated withBioresobable Vascular Scaffold for coronary disease

Exclusion Criteria:

History of allergy to contrast
Serum Creatinine > 2.0 mg/dl
Severe arrhythmia
Pregnancy or breast feeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients treated with Bioresobable Vascular Scaffold for coronary disease

Sampling Method

Non-Probability Sample

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
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