NCT06322914

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
493

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

11.8 years

First QC Date

March 12, 2024

Last Update Submit

March 19, 2024

Conditions

Keywords

Chronic total occlusion (CTO)A Novel Scoring Systemthe Success of Percutaneous Coronary Interventions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with CTO lesions who underwent percutaneous recanalization attempts recruited between January 2012 and November 2023

You may qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (5)

  • 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.

    PMID: 21349461BACKGROUND
  • 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.

    PMID: 26762904BACKGROUND
  • 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.

    PMID: 28171874BACKGROUND
  • 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.

    PMID: 30711551BACKGROUND
  • 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.

    PMID: 32948391BACKGROUND

Study Officials

  • Chunjian Li, Dr,PhD

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiology

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 21, 2024

Study Start

January 1, 2012

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

March 21, 2024

Record last verified: 2024-03

Locations