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NCT02981134 Clinical Trial

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

Coronary Disease Clinical Trial

— CT BVS  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02981134
Other study ID # AMCCV2016-25
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date December 2021
Est. completion date December 2023

Study information
Verified date July 2021
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Computed tomographic scan
after 1year of BVS implantation, computed tomographic scan will be performed

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (2)
Lead Sponsor Collaborator
Jung-min Ahn CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Computed tomographic scan parameters Computed tomographic scan parameters predicting clinical outcomes 3 years
Secondary Restenosis Restenosis on computed tomographic scan 1 year
Secondary Thrombosis Thrombosis on computed tomographic scan 1 year
Secondary Lumen loss lumen loss: the change in minimal lumen diameter on computed tomographic scan 1 year
Secondary Positive predictive value Positive predictive value on computed tomographic scan 3 years
Secondary Clinical outcomes Death, target vessel myocardial infarction, clinically driven revascularization 3 years
Secondary Proportion of analyzable lesion small vessel defined diameter less than 3.0 mm, bifurcation, overlapped lesion 3 years
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