Chronic Total Occlusion (CTO)NCT06322914
A Novel Scoring System for Predicting the Success of PCI in Patients With CTO
An observational study of Chronic Total Occlusion (CTO), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The investigators conducted a retrospective, single-center observational registry upon which one novel scoring system was formed and evaluated for their accuracy in predicting technical success. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Total Occlusion (CTO)
- How many people
- 493 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Nov 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with CTO lesions who underwent percutaneous recanalization attempts recruited between January 2012 and November 2023
Who may be able to join
- complete occlusion of the coronary artery, confirmed by coronary angiography with TIMI flow grade 0, and occlusion for ≥3 months;
- presence of angina or angina-equivalent symptoms ; undergo coronary intervention;
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: A Novel Scoring System for Predicting the Success of Percutaneous Coronary Interventions in Patients With Chronic Total Occlusion
The investigators conducted a retrospective, single-center observational registry upon which one novel scoring system was formed and evaluated for their accuracy in predicting technical success. The investigators reviewed the clinical and angiographic records of 432 patients with 459 CTO lesions who underwent percutaneous recanalization attempts recruited between January 2012 and November 2023. The investigators aims to develop and validate a novel scoring system for predicting CTO-PCI success.
Read the detailed description
Chronic total occlusions (CTO) accounting for about 15-20% of coronary artery lesions can be challenging and only 10-15% of patients undergo successful percutaneous coronary intervention (PCI) .Thanks to the technological and device advances, the marked improvement of PCI success rates could be seen. However, in contrast to non-CTO lesions, these procedures are accompanied by longer procedure time, contrast and radiation burden, and higher complication rates. The possibility to predict which CTOs are more likely to be treated successfully is still of utmost importance for patient selection. Several scores have been proposed to predict the procedural success rate, such as J-CTO, CL-Score, Progress-Score et al , J-CTO is widely accepted. But Karatasakis et al.showed that these scores performed moderately in predicting technical outcome, while ignoring many factors such as stumpless lesion which may exert an influence on the procedural success. The investigators aims to develop and validate a novel scoring system for predicting CTO-PCI success.
- Conditions
- Chronic Total Occlusion (CTO)
- Keywords
- Chronic total occlusion (CTO), A Novel Scoring System, the Success of Percutaneous Coronary Interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Technical successful group | Technical success of CTO PCI was defined as successful CTO revascularization with achievement of <30% residual diameter stenosis within the treated segment and restoration of antegrade TIMI flow grade 3. | |
| Technical unsuccessful group | Technical unsuccess of CTO PCI was defined as unsuccessful CTO revascularization（guide wire or stent cannot cross through the lesion） |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCI technical success
Technical success of CTO PCI was defined as successful revascularization with <30% residual diameter stenosis and restoration of antegrade TIMI flow grade 3
of <30% residual diameter stenosis within the treated segment and restoration of antegrade TIMI flow grade 3.
Measured: immediately after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study startJan 2012
- Primary completionNov 2023
- Study completionNov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Total Occlusion (CTO)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 493 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjian Li, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Chunjian Li, Dr,PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322914
- Sponsor's protocol ID
- 029
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Morino Y, Abe M, Morimoto T, Kimura T, Hayashi Y, Muramatsu T, Ochiai M, Noguchi Y, Kato K, Shibata Y, Hiasa Y, Doi O, Yamashita T, Hinohara T, Tanaka H, Mitsudo K; J-CTO Registry Investigators. Predicting successful guidewire crossing through chronic total occlusion of native coronary lesions within 30 minutes: the J-CTO (Multicenter CTO Registry in Japan) score as a difficulty grading and time assessment tool. JACC Cardiovasc Interv. 2011 Feb;4(2):213-21. doi: 10.1016/j.jcin.2010.09.024.
PubMed 21349461Christopoulos G, Kandzari DE, Yeh RW, Jaffer FA, Karmpaliotis D, Wyman MR, Alaswad K, Lombardi W, Grantham JA, Moses J, Christakopoulos G, Tarar MNJ, Rangan BV, Lembo N, Garcia S, Cipher D, Thompson CA, Banerjee S, Brilakis ES. Development and Validation of a Novel Scoring System for Predicting Technical Success of Chronic Total Occlusion Percutaneous Coronary Interventions: The PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) Score. JACC Cardiovasc Interv. 2016 Jan 11;9(1):1-9. doi: 10.1016/j.jcin.2015.09.022.
PubMed 26762904Jin C, Kim MH, Kim SJ, Lee KM, Kim TH, Cho YR, Serebruany VL. Predicting Successful Recanalization in Patients with Native Coronary Chronic Total Occlusion: The Busan CTO Score. Cardiology. 2017;137(2):83-91. doi: 10.1159/000455824. Epub 2017 Feb 8.
PubMed 28171874Szijgyarto Z, Rampat R, Werner GS, Ho C, Reifart N, Lefevre T, Louvard Y, Avran A, Kambis M, Buettner HJ, Di Mario C, Gershlick A, Escaned J, Sianos G, Galassi A, Garbo R, Goktekin O, Meyer-Gessner M, Lauer B, Elhadad S, Bufe A, Boudou N, Sievert H, Martin-Yuste V, Thuesen L, Erglis A, Christiansen E, Spratt J, Bryniarski L, Clayton T, Hildick-Smith D. Derivation and Validation of a Chronic Total Coronary Occlusion Intervention Procedural Success Score From the 20,000-Patient EuroCTO Registry: The EuroCTO (CASTLE) Score. JACC Cardiovasc Interv. 2019 Feb 25;12(4):335-342. doi: 10.1016/j.jcin.2018.11.020. Epub 2019 Jan 30.
PubMed 30711551Rigueira J, Aguiar-Ricardo I, Nobre Menezes M, Santos R, Rodrigues T, Cunha N, G Francisco AR, Marques da Costa J, Carrilho Ferreira P, Jorge C, Infante Oliveira E, Duarte J, Torres D, Pinto Cardoso P, Pinto FJ, Canas da Silva P. The CTo-aBCDE score: A new predictor of success in chronic total occlusions. Rev Port Cardiol (Engl Ed). 2020 Oct;39(10):575-582. doi: 10.1016/j.repc.2020.05.007. Epub 2020 Sep 15. English, Portuguese.
PubMed 32948391
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Scoring System for Predicting the Success of Percutaneous Coronary Interventions in Patients With Chronic Total Occlusion
- ClinicalTrials.gov ID
- NCT06322914
- Acronym / sponsor ID
- 029
- Conditions
- Chronic Total Occlusion (CTO)
- Keywords
- Chronic total occlusion (CTO), A Novel Scoring System, the Success of Percutaneous Coronary Interventions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 493 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Nov 2023 (actual)
- Study completion
- Nov 2023 (actual)
- First posted
- 21 Mar 2024 (actual)
- 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 investigators conducted a retrospective, single-center observational registry upon which one novel scoring system was formed and evaluated for their accuracy in predicting technical success. The investigators reviewed the clinical and angiographic records of 432 patients with 459 CTO lesions who underwent percutaneous recanalization attempts recruited between January 2012 and November 2023. The investigators aims to develop and validate a novel scoring system for predicting CTO-PCI success.
Detailed description
Chronic total occlusions (CTO) accounting for about 15-20% of coronary artery lesions can be challenging and only 10-15% of patients undergo successful percutaneous coronary intervention (PCI) .Thanks to the technological and device advances, the marked improvement of PCI success rates could be seen. However, in contrast to non-CTO lesions, these procedures are accompanied by longer procedure time, contrast and radiation burden, and higher complication rates. The possibility to predict which CTOs are more likely to be treated successfully is still of utmost importance for patient selection. Several scores have been proposed to predict the procedural success rate, such as J-CTO, CL-Score, Progress-Score et al , J-CTO is widely accepted. But Karatasakis et al.showed that these scores performed moderately in predicting technical outcome, while ignoring many factors such as stumpless lesion which may exert an influence on the procedural success. The investigators aims to develop and validate a novel scoring system for predicting CTO-PCI success.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technical successful group | – | –Technical success of CTO PCI was defined as successful CTO revascularization with achievement of <30% residual diameter stenosis within the treated segment and restoration of antegrade TIMI flow grade 3. |
| Technical unsuccessful group | – | –Technical unsuccess of CTO PCI was defined as unsuccessful CTO revascularization（guide wire or stent cannot cross through the lesion） |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with CTO lesions who underwent percutaneous recanalization attempts recruited between January 2012 and November 2023
Key inclusion criteria (2 listed)
- complete occlusion of the coronary artery, confirmed by coronary angiography with TIMI flow grade 0, and occlusion for ≥3 months;
- presence of angina or angina-equivalent symptoms ; undergo coronary intervention;
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PCI technical success
Time frame: immediately after PCI
Technical success of CTO PCI was defined as successful revascularization with <30% residual diameter stenosis and restoration of antegrade TIMI flow grade 3 of <30% residual diameter stenosis within the treated segment and restoration of antegrade TIMI flow grade 3.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Background: PubMed 21349461Morino Y, Abe M, Morimoto T, Kimura T, Hayashi Y, Muramatsu T, Ochiai M, Noguchi Y, Kato K, Shibata Y, Hiasa Y, Doi O, Yamashita T, Hinohara T, Tanaka H, Mitsudo K; J-CTO Registry Investigators. Predicting successful guidewire crossing through chronic total occlusion of native coronary lesions within 30 minutes: the J-CTO (Multicenter CTO Registry in Japan) score as a difficulty grading and time assessment tool. JACC Cardiovasc Interv. 2011 Feb;4(2):213-21. doi: 10.1016/j.jcin.2010.09.024.
- Background: PubMed 26762904Christopoulos G, Kandzari DE, Yeh RW, Jaffer FA, Karmpaliotis D, Wyman MR, Alaswad K, Lombardi W, Grantham JA, Moses J, Christakopoulos G, Tarar MNJ, Rangan BV, Lembo N, Garcia S, Cipher D, Thompson CA, Banerjee S, Brilakis ES. Development and Validation of a Novel Scoring System for Predicting Technical Success of Chronic Total Occlusion Percutaneous Coronary Interventions: The PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) Score. JACC Cardiovasc Interv. 2016 Jan 11;9(1):1-9. doi: 10.1016/j.jcin.2015.09.022.
- Background: PubMed 28171874Jin C, Kim MH, Kim SJ, Lee KM, Kim TH, Cho YR, Serebruany VL. Predicting Successful Recanalization in Patients with Native Coronary Chronic Total Occlusion: The Busan CTO Score. Cardiology. 2017;137(2):83-91. doi: 10.1159/000455824. Epub 2017 Feb 8.
- Background: PubMed 30711551Szijgyarto Z, Rampat R, Werner GS, Ho C, Reifart N, Lefevre T, Louvard Y, Avran A, Kambis M, Buettner HJ, Di Mario C, Gershlick A, Escaned J, Sianos G, Galassi A, Garbo R, Goktekin O, Meyer-Gessner M, Lauer B, Elhadad S, Bufe A, Boudou N, Sievert H, Martin-Yuste V, Thuesen L, Erglis A, Christiansen E, Spratt J, Bryniarski L, Clayton T, Hildick-Smith D. Derivation and Validation of a Chronic Total Coronary Occlusion Intervention Procedural Success Score From the 20,000-Patient EuroCTO Registry: The EuroCTO (CASTLE) Score. JACC Cardiovasc Interv. 2019 Feb 25;12(4):335-342. doi: 10.1016/j.jcin.2018.11.020. Epub 2019 Jan 30.
- Background: PubMed 32948391Rigueira J, Aguiar-Ricardo I, Nobre Menezes M, Santos R, Rodrigues T, Cunha N, G Francisco AR, Marques da Costa J, Carrilho Ferreira P, Jorge C, Infante Oliveira E, Duarte J, Torres D, Pinto Cardoso P, Pinto FJ, Canas da Silva P. The CTo-aBCDE score: A new predictor of success in chronic total occlusions. Rev Port Cardiol (Engl Ed). 2020 Oct;39(10):575-582. doi: 10.1016/j.repc.2020.05.007. Epub 2020 Sep 15. English, Portuguese.
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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.
Chunjian Li, Dr,PhD principal investigator
Study Principal Investigator
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 Chronic Total Occlusion (CTO), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 21 Mar 2024. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PCI technical success (time frame: immediately after 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 NCT06322914, which also lists 5 linked publications.
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 21 Mar 2024.