Application of Coronary Artery Chronic Total Occlusion Scoring Systems

Chronic Total Occlusion of Coronary Artery Clinical Trial

— CTO-PCI  

Official title:

Application of Coronary Artery Chronic Total Occlusion (CTO) Scoring Systems Detecting Their Prediction Ability on CTO Percutaneous Coronary Intervention (PCI) Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05883579
• Other study ID #: CTO-PCI scores application
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: May 2023
• Source: Assiut University
• Contact: Khaled Qayed, Master
• Phone: +886973547398
• Email: khaledsaberqayed66[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Studying the prediction ability of different CTO scoring systems on Asian CTO PCI population with their relation to technical success and developing a newer stepwise approach depending on these CTO scoring systems for choosing the suggested successful approach considering collateral channel assessment.

Description:

Study of applying the Japenese CTO, Castle and Progress CTO scores on all coronary CTO PCI cohort done at national Taiwan university hospital (NTUH) Study tools: 1. Basal demographic data collection( age, cardiovascular risk factors, patients clinical data, lesion characteristics, periprocedural complications). 2. The Japanese Chronic Total Occlusion (J-CTO) score calculated for assessment of CTO procedures complexity and predict the likelihood of guide wire crossing within 30 min, as assembled by Morino et al. The J-CTO score is the sum of the following 5 binary parameters: blunt proximal cap, calcification, bending >45°, length of occluded segment >20 mm, and previously failed PCI attempt. Each of these independent variables was assigned a value of 1 when present. With increasing probability of difficulty of wire crossing from 0 as easy till 5 as very difficult. 3. Also, the PROGRESS-CTO score calculated (reference website: https://www.progresscto.org/cto with evaluation of 4 baseline angiographic characteristics (proximal cap ambiguity, absence of retrograde collaterals, moderate or severe tortuosity, and LCX CTO) used to determine the likelihood of technical success with CTO PCI. Each of these independent variables was assigned a value of 1 when present. With increasing probability of difficulty of success from 0 as easy till 5 as very difficult. 4. Euro CTO CASTLE scoring calculation The CASTLE (coronary artery bypass graft history, age, stump anatomy, tortuosity degree, length of occlusion, and extent of calcification) model applied retrospectively on the patients with every item taking 1 point if present And Technical failure rates range from 8% (CASTLE score 0 to 1) to 35% (CASTLE score ≥4). 5. Collateral assessment including type (septal, epicardial or bypass grafts), size by Werner classification [is graded as: 0, no visible connection between the donor and the recipient coronary artery; 1, thread-like connection between the donor and the recipient coronary artery; 2, side-branch like connection between the donor and the recipient coronary artery], tortuosity degree as by the CC scoring system of the NTUH--> Channel tortuosity caculated as the presence of ≥2 high-frequency, successive curves (within 2 mm) in the context of epicardial collaterals and ≥1 high-frequency curve that failed to uncoil in diastole for septal channels (thus a measure of channel distensibility). A high-frequency curve is defined as a curve that is >180° occurring within a segment length <3× the diameter of the collateral. And all these scores references and calculation items are mentioned in the references below….

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: August 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All coronary CTO PCI procedures done at national Taiwan university hospital (NTUH) with their data available for analysis from 2015 till the study data collection step.

Exclusion Criteria:

• Patients whom data not completed

Related Conditions & MeSH terms

• Chronic Total Occlusion of Coronary Artery

Intervention

Procedure:
• percutaneous coronary intervention
doing percutaneous revascularization of chronic coronary total occlusion.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Assiut University	National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (13)

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 — View Citation

Ellis SG, Burke MN, Murad MB, Graham JJ, Badawi R, Toma C, Meltser H, Nair R, Buller C, Whitlow PL; CAPS Group. Predictors of Successful Hybrid-Approach Chronic Total Coronary Artery Occlusion Stenting: An Improved Model With Novel Correlates. JACC Cardio — View Citation

Fefer P, Knudtson ML, Cheema AN, Galbraith PD, Osherov AB, Yalonetsky S, Gannot S, Samuel M, Weisbrod M, Bierstone D, Sparkes JD, Wright GA, Strauss BH. Current perspectives on coronary chronic total occlusions: the Canadian Multicenter Chronic Total Occl — View Citation

Galassi AR, Boukhris M, Azzarelli S, Castaing M, Marza F, Tomasello SD. Percutaneous Coronary Revascularization for Chronic Total Occlusions: A Novel Predictive Score of Technical Failure Using Advanced Technologies. JACC Cardiovasc Interv. 2016 May 9;9(9 — View Citation

Galassi AR, Werner GS, Boukhris M, Azzalini L, Mashayekhi K, Carlino M, Avran A, Konstantinidis NV, Grancini L, Bryniarski L, Garbo R, Bozinovic N, Gershlick AH, Rathore S, Di Mario C, Louvard Y, Reifart N, Sianos G. Percutaneous recanalisation of chronic — View Citation

Huang CC, Lee CK, Meng SW, Hung CS, Chen YH, Lin MS, Yeh CF, Kao HL. Collateral Channel Size and Tortuosity Predict Retrograde Percutaneous Coronary Intervention Success for Chronic Total Occlusion. Circ Cardiovasc Interv. 2018 Jan;11(1):e005124. doi: 10. — View Citation

Kalogeropoulos AS, Alsanjari O, Keeble TR, Tang KH, Konstantinou K, Katsikis A, Jagathesan R, Aggarwal RK, Clesham GJ, Kelly PA, Werner GS, Hildick-Smith D, Davies JR, Karamasis G. CASTLE score versus J-CTO score for the prediction of technical success in — View Citation

Li Y, Xu N, Zhang J, Li M, Lu Z, Wei M, Lu B, Zhang Y. Procedural success of CTO recanalization: Comparison of the J-CTO score determined by coronary CT angiography to invasive angiography. J Cardiovasc Comput Tomogr. 2015 Nov-Dec;9(6):578-84. doi: 10.101 — 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 tot — View Citation

Salinas P, Gonzalo N, Moreno VH, Fuentes M, Santos-Martinez S, Fernandez-Diaz JA, Amat-Santos IJ, Ojeda FB, Borrego JC, Cuesta J, Hernandez JMT, Diego-Nieto A, Dubois D, Galeote G, Goicolea J, Gutierrez A, Jimenez-Fernandez M, Jimenez-Mazuecos J, Jurado A — 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, Marti — View Citation

Tajti P, Burke MN, Karmpaliotis D, Alaswad K, Werner GS, Azzalini L, Carlino M, Patel M, Mashayekhi K, Egred M, Krestyaninov O, Khelimskii D, Nicholson WJ, Ungi I, Galassi AR, Banerjee S, Brilakis ES. Update in the Percutaneous Management of Coronary Chro — View Citation

Werner GS, Ferrari M, Heinke S, Kuethe F, Surber R, Richartz BM, Figulla HR. Angiographic assessment of collateral connections in comparison with invasively determined collateral function in chronic coronary occlusions. Circulation. 2003 Apr 22;107(15):19 — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of the effecacy of using CTO scoring systems (J-CTO scoring, Castle Score and progress scoring along with the CC scoring in prediction of technical success.	comaprling the three CTO scores for all CTO PCI patients done by experienced operator ( J-CTO scoring, Castle Score and progress scoring ) for prediction of technical success with higher scores indicating higher probability of difficulty along with the CC scoring in predicting higher chances of technical success in retrograde CTO PCI patients.	Two months