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

Chronic Total Occlusion (CTO) Clinical Trial

Official title:

A Novel Scoring System for Predicting the Success of Percutaneous Coronary Interventions in Patients With Chronic Total Occlusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06322914
• Other study ID #: 029
• Status: Completed
• Start date: January 2012
• Est. completion date: November 2023

Study information

• Verified date: March 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 493
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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: -

Related Conditions & MeSH terms

• Chronic Total Occlusion (CTO)

Locations

Country	Name	City	State
China	First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	immediately after PCI