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

Sponsor

Jung-min Ahn (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02981134

Collaborator

CardioVascular Research Foundation, Korea (Other)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease	Procedure: Computed tomographic scan

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Usefulness of Coronary CT Scan After Everolimus-eluting Bioabsorbable Scaffold Implantation for Coronary Artery Disease; A Single Center, Prospective Observational Study

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
bioabsorbable scaffold Patients with BVS(bioabsorbable scaffold) for coronary stenosis	Procedure: Computed tomographic scan after 1year of BVS implantation, computed tomographic scan will be performed

Arm

Intervention/Treatment

bioabsorbable scaffold

Patients with BVS(bioabsorbable scaffold) for coronary stenosis

Procedure: Computed tomographic scan

after 1year of BVS implantation, computed tomographic scan will be performed

Outcome Measures

Primary Outcome Measures

Computed tomographic scan parameters [3 years]
Computed tomographic scan parameters predicting clinical outcomes

Secondary Outcome Measures

Restenosis [1 year]
Restenosis on computed tomographic scan
Thrombosis [1 year]
Thrombosis on computed tomographic scan
Lumen loss [1 year]
lumen loss: the change in minimal lumen diameter on computed tomographic scan
Positive predictive value [3 years]
Positive predictive value on computed tomographic scan
Clinical outcomes [3 years]
Death, target vessel myocardial infarction, clinically driven revascularization
Proportion of analyzable lesion [3 years]
small vessel defined diameter less than 3.0 mm, bifurcation, overlapped lesion

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

Jung-min Ahn
CardioVascular Research Foundation, Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT02981134

Other Study ID Numbers:

AMCCV2016-25

First Posted:

Dec 5, 2016

Last Update Posted:

Jul 23, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Jung-min Ahn, Assistant professor, Department of Cardiology, Heart Institute, University of Ulsan College of Medicine, Asan Medical Center

bioabsorbable scaffold

computed tomography

Additional relevant MeSH terms:

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Study Results

No Results Posted as of Jul 23, 2021