Coronary Disease Clinical Trial
— CT BVSOfficial title:
The Usefulness of Coronary CT Scan After Everolimus-eluting Bioabsorbable Scaffold Implantation for Coronary Artery Disease; A Single Center, Prospective Observational Study
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Status | Withdrawn |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 |
Verified date | July 2021 |
Source | Asan Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Jung-min Ahn | CardioVascular Research Foundation, Korea |
Korea, Republic of,
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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