Coronary Artery Obstructive DiseaseNCT02037698
Role of CT Scan for the Successful Recanalization of Chronic Total Occlusion; a Randomized Comparison Between 3D CT-guided PCI vs. Conventional Treatment (CT-CTO Trial)
A study testing Pre-PCI coronary CT scan in people with Coronary Artery Obstructive Disease and Chronic Total Occlusion Lesions, run by Yonsei University at 1 site in South Korea.
Trial summary
The revascularization of chronic total occlusion of coronary arteries (CTO) is the most challenging procedure for the coronary intervention. For the initial period for CTO intervention, percutaneous coronary artery intervention (PCI) of CTO lesions are associated with low procedural success rates about 70%. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Obstructive Disease, Chronic Total Occlusion Lesions
- What is being tested?
- Pre-PCI coronary CT scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Dec 2020
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (age >19 years) with CTO (TIMI = 0 and estimated duration of occlusion at least 3 months)
- Typical symptomatic angina or positive stress test in various functional studies evaluating ischemia
- Eligible patients for pre-procedural CT scan and coronary angiogram
Who cannot join
- Cardiogenic shock or ejection fraction < 25%
- CTO lesions at DES restenosis or graft occlusion lesion
- Significant left main stenosis
- Retry of same CTO lesion within 2 weeks
- Acute myocardial infarction within 48 hours
- Hypersensitivity to aspirin, clopidogrel, or -limus families / or contraindication to antiplatelet agents
Show all 9Show fewer
- Severe hepatic dysfunction (≥3 times normal reference values)
- Life expectancy < 1 years
- Pregnant women or women with potential childbearing
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology, Severance Cardiovascular Hospital
Seoul, 120-752
Yangsoo Jang, MD, 82-2-2228-8460, jangys1212@yuhs.ac
About this study
The revascularization of chronic total occlusion of coronary arteries (CTO) is the most challenging procedure for the coronary intervention. For the initial period for CTO intervention, percutaneous coronary artery intervention (PCI) of CTO lesions are associated with low procedural success rates about 70%. Recently, the success rate of the recanalization of CTOs has been raised in several studies.
Coronary CT angiography (CCTA) is an effective noninvasive diagnostic modality for detecting coronary artery disease. CCTA can visualize the complete anatomy of coronary arteries in contrast to conventional coronary angiography, reducing the deferral rates from CTO intervention. Assessment of characteristics of CTO lesions by pre-procedural CCTA could help to determine revascularization strategy and estimate the procedure time, leading to lower procedural complications. We suggest that success rates and clinical outcome of intervention of CTO lesion can be improved by pre-procedural CCTA.
- Being tested
- Pre-PCI coronary CT scan
- Keywords
- CTO, CT, Revascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-PCI coronary CT scanDevice
Coronary CT scan before CTO PCI
| Study group | Role | What they receive |
|---|---|---|
| Pre-PCI CT scan group | Experimental | Pre-PCI CT scan Receives: Device: Pre-PCI coronary CT scan |
| Control group | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful CTO recanalization
Incidence of the successful CTO recanalization between pre-PCI CT scan group versus control group
Measured: Immediately after CTO PCI
Secondary outcomes (1)
Incidence of MACEs
Comparison of major adverse cardiac events (MACE), between ZES and EES implantation.
Measured: 12 months after index PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Obstructive DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037698
- Sponsor's protocol ID
- 1-2013-0062
- Status last verified
- Jan 2020
- First submitted
- 18 Dec 2013
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hong SJ, Kim BK, Cho I, Kim HY, Rha SW, Lee SH, Park SM, Kim YH, Chang HJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y; CT-CTO Investigators. Effect of Coronary CTA on Chronic Total Occlusion Percutaneous Coronary Intervention: A Randomized Trial. JACC Cardiovasc Imaging. 2021 Oct;14(10):1993-2004. doi: 10.1016/j.jcmg.2021.04.013. Epub 2021 Jun 16.
PubMed 34147439
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of CT Scan for the Successful Recanalization of Chronic Total Occlusion; a Randomized Comparison Between 3D CT-guided PCI vs. Conventional Treatment (CT-CTO Trial)
- ClinicalTrials.gov ID
- NCT02037698
- Acronym / sponsor ID
- 1-2013-0062
- Keywords
- CTO, CT, Revascularization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 16 Jan 2014 (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.
The revascularization of chronic total occlusion of coronary arteries (CTO) is the most challenging procedure for the coronary intervention. For the initial period for CTO intervention, percutaneous coronary artery intervention (PCI) of CTO lesions are associated with low procedural success rates about 70%. Recently, the success rate of the recanalization of CTOs has been raised in several studies.
Coronary CT angiography (CCTA) is an effective noninvasive diagnostic modality for detecting coronary artery disease. CCTA can visualize the complete anatomy of coronary arteries in contrast to conventional coronary angiography, reducing the deferral rates from CTO intervention. Assessment of characteristics of CTO lesions by pre-procedural CCTA could help to determine revascularization strategy and estimate the procedure time, leading to lower procedural complications. We suggest that success rates and clinical outcome of intervention of CTO lesion can be improved by pre-procedural CCTA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-PCI CT scan group | Experimental | Device: Pre-PCI coronary CT scanPre-PCI CT scan |
| Control group | No intervention | –Control |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients (age >19 years) with CTO (TIMI = 0 and estimated duration of occlusion at least 3 months)
- Typical symptomatic angina or positive stress test in various functional studies evaluating ischemia
- Eligible patients for pre-procedural CT scan and coronary angiogram
Key exclusion criteria (9 listed)
- Cardiogenic shock or ejection fraction < 25%
- CTO lesions at DES restenosis or graft occlusion lesion
- Significant left main stenosis
- Retry of same CTO lesion within 2 weeks
- Acute myocardial infarction within 48 hours
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 |
|---|---|---|
| Pre-PCI coronary CT scanCoronary CT scan before CTO PCI | Device | Pre-PCI CT scan group |
Primary outcome
Successful CTO recanalization
Time frame: Immediately after CTO PCI
Incidence of the successful CTO recanalization between pre-PCI CT scan group versus control group
1 secondary outcome
Incidence of MACEs
Time frame: 12 months after index PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Derived from this study: PubMed 34147439Hong SJ, Kim BK, Cho I, Kim HY, Rha SW, Lee SH, Park SM, Kim YH, Chang HJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y; CT-CTO Investigators. Effect of Coronary CTA on Chronic Total Occlusion Percutaneous Coronary Intervention: A Randomized Trial. JACC Cardiovasc Imaging. 2021 Oct;14(10):1993-2004. doi: 10.1016/j.jcmg.2021.04.013. Epub 2021 Jun 16.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-PCI coronary CT scan in people with Coronary Artery Obstructive Disease and Chronic Total Occlusion Lesions, run by Yonsei University 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 23 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yangsoo Jang, MD (82-2-2228-8460, jangys1212@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful CTO recanalization (time frame: Immediately after CTO PCI). 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 NCT02037698, which also lists 1 linked publication.
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 Jan 2020.