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

An observational study of Coronary Disease, run by Jung-min Ahn at 1 site in South Korea.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

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. Read more about this study

Who is it for?: Ages 19 to 80 years
Conditions the study is for: Coronary Disease
What is being tested?: Computed tomographic scan
Type of treatment: Surgery or procedure
How many people: 0 participants
Where: 1 siteSouth Korea
Study dates: Dec 2021to Dec 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients treated with Bioresobable Vascular Scaffold for coronary disease

Who may be able to join

Patients treated withBioresobable Vascular Scaffold for coronary disease

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Asan Medical Center
Seoul

Other trials in South Korea

About this study

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

Conditions: Coronary Disease
Being tested: Computed tomographic scan
Keywords: bioabsorbable scaffold, computed tomography
Medical subject headings: Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Computed tomographic scanProcedure or surgery
after 1year of BVS implantation, computed tomographic scan will be performed

Study groups in NCT02981134
Study group	Role	What they receive
bioabsorbable scaffold		Patients with BVS(bioabsorbable scaffold) for coronary stenosis Receives: Procedure: Computed tomographic scan

What is being measured

The primary outcome is the main question the study is designed to answer.

Computed tomographic scan parameters
Computed tomographic scan parameters predicting clinical outcomes
Measured: 3 years

Secondary outcomes (6)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2021Dec 2023

First posted5 Dec 2016 (estimated)
Study startDec 2021 (estimated)
Primary completionJun 2023 (estimated)
Study completionDec 2023 (estimated)

Why it stopped: This study will be revived with retrospective design.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Coronary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02981134
Sponsor's protocol ID: AMCCV2016-25
Acronym: CT BVS
Status last verified: Jul 2021
First submitted: 30 Nov 2016
Last updated: 23 Jul 2021
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Usefulness of Coronary CT Scan After Everolimus-eluting Bioabsorbable Scaffold Implantation for Coronary Artery Disease; A Single Center, Prospective Observational Study
ClinicalTrials.gov ID: NCT02981134
Acronym / sponsor ID: CT BVS / AMCCV2016-25
Conditions: Coronary Disease
Keywords: bioabsorbable scaffold, computed tomography
Study type: Observational
Recruitment status: WithdrawnReason stopped: This study will be revived with retrospective design.
Enrolment: 0 participants (actual)
Lead sponsor: Jung-min AhnUniversity, hospital or other
Collaborators: CardioVascular Research Foundation, Korea
Study start: Dec 2021 (estimated)
Primary completion: Jun 2023 (estimated)
Study completion: Dec 2023 (estimated)
First posted: 5 Dec 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
bioabsorbable scaffold	–	Procedure: Computed tomographic scanPatients with BVS(bioabsorbable scaffold) for coronary stenosis

Who may qualify

Ages: 19 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients treated with Bioresobable Vascular Scaffold for coronary disease

Key inclusion criteria (1 listed)

Patients treated withBioresobable Vascular Scaffold for coronary disease

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Computed tomographic scanafter 1year of BVS implantation, computed tomographic scan will be performed	Procedure or surgery	bioabsorbable scaffold

Primary outcome

Computed tomographic scan parameters
Time frame: 3 years
Computed tomographic scan parameters predicting clinical outcomes

6 secondary outcomes

Restenosis
Time frame: 1 year
Thrombosis
Time frame: 1 year
Lumen loss
Time frame: 1 year
Positive predictive value
Time frame: 3 years
Clinical outcomes
Time frame: 3 years
Proportion of analyzable lesion
Time frame: 3 years

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
Individual participant dataSharing planned: Undecided

Related trials for Coronary Disease

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Disease, run by Jung-min Ahn at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Computed tomographic scan parameters (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02981134.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.