A Novel Scoring System for Predicting the Success of PCI in Patients With CTO

NCT ID: NCT06322914

Last Updated: 2024-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

493 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2023-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Total Occlusion (CTO)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Technical unsuccessful group

Technical unsuccess of CTO PCI was defined as unsuccessful CTO revascularization(guide wire or stent cannot cross through the lesion)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. complete occlusion of the coronary artery, confirmed by coronary angiography with TIMI flow grade 0, and occlusion for ≥3 months;
2. presence of angina or angina-equivalent symptoms ; undergo coronary intervention;

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chunjian Li

Director of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chunjian Li, Dr,PhD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21349461 (View on PubMed)

Christopoulos 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.

Reference Type BACKGROUND
PMID: 26762904 (View on PubMed)

Jin 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.

Reference Type BACKGROUND
PMID: 28171874 (View on PubMed)

Szijgyarto 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.

Reference Type BACKGROUND
PMID: 30711551 (View on PubMed)

Rigueira 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.

Reference Type BACKGROUND
PMID: 32948391 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

029

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Outcomes of Isolated LCx Occlusion
NCT06750328 NOT_YET_RECRUITING
Chronic Total Occlusion Registry
NCT02352818 RECRUITING
Japanese CTO PCI Expert Registry
NCT01889459 RECRUITING
Kitasato PCI Registry
NCT05308329 UNKNOWN