TRIO CTO (Taiwan Research Initiative on Coronary Total Occlusion)

The Multicenter Study to Evaluate Clinical and Angiographic Factors in Patients With Coronary Artery Chronic Total Occlusion in Taiwan

Coronary chronic total occlusions (CTO) present a significant challenge in the field of interventional cardiology. These complex lesions, characterized by complete blockage of a coronary artery for a prolonged duration, often require specialized techniques and strategies to achieve successful revascularization.

Study Overview

• Status: Recruiting
• Conditions: Chronic Total Occlusion (CTO)
• Intervention / Treatment: Procedure: Percutaneous coronary intervention of coronary chronic total occlusion

Detailed Description

Using this consortium, we will establish a multicenter cohort to evaluate the clinical parameters, angiographic characteristics, interventional techniques, and clinical outcomes involved in coronary CTO intervention. 3 subprojects are listed here.

Subproject 1 intends to develop a novel algorithm integrating antegrade and retrograde scoring system to optimize the CTO intervention and determine the optimal timing for primary retrograde approach. Current algorithm for CTO intervention.

Subproject 2 aims to examine the strategies and outcomes of CTO involving bifurcations. Bifurcation CTO lesions present unique challenges due to their complex anatomy. Opening of the main vessel while preserving important branches is crucial for ensuring favorable long-term clinical prognosis. This subproject will investigate different strategies and devices employed in bifurcation CTO PCI to assess their efficacy and safety outcomes.

Subproject 3 investigates the treatment strategies for right coronary artery (RCA) CTOs with concomitant left main disease, which present a unique and intricate scenario, requiring careful consideration of revascularization strategies.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Chih Fan Yeh; Phone Number: 263912 +8862-23123456; Email: nicholas.yeh@gmail.com

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Ying-Chang Tung, MD; Phone Number: +8863-3281200; Email: cgmhswd@cgmh.org.tw
  • Taipei, Taiwan
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: Chun -Chin Chang, MD, PhD; Phone Number: +8862-28712121; Email: ccchang16@vghtpe.gov.tw
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chih-Fan Yeh, MD, PhD; Phone Number: 262152 +886223123456; Email: nicholas.yeh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

1. Over 20 years old
2. Chronic total occlusion confirmed by coronary angiography, and noted for more than 3 months

Description

Inclusion criteria

1. Over 20 years old
2. Chronic total occlusion confirmed by coronary angiography, and noted for more than 3 months

Exclusion criteria Nil

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Successful CTO intervention; Successful CTO intervention, subgrouped by strategies, ex. antegrade or retrograde approach	Procedure: Percutaneous coronary intervention of coronary chronic total occlusion; Coronary CTO was identified by coronary angiography, and its revascularization was attempted by either antegrade, retrograde or both approach.; Other Names: PCI to CTO
Failed CTO intervention; Failed CTO intervention, subgrouped by strategies, ex. antegrade or retrograde approach	Procedure: Percutaneous coronary intervention of coronary chronic total occlusion; Coronary CTO was identified by coronary angiography, and its revascularization was attempted by either antegrade, retrograde or both approach.; Other Names: PCI to CTO
No CTO intervention; CTO was not intervened

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with technical success of CTO revascularization	Successful CTO recanalization with <20% residual stenosis within the treated segment and restoration of Thrombolysis in Myocardial Infarction grade 3 antegrade flow, without side branch loss	1 day
Number of participants with collateral channel tracking success	retrograde guidewire crossing the CC to reach the distal cap of CTO segment.	1 day
Number of participants with major adverse cerebral cardiovascular events	Death, CV death, myocardial infarction, stroke, repeat revascularization	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with periprocedural myocardial infarction	Confirmed by	1 day
Number of participants with periprocedural complications	Periprocedural myocardial infarction, vessel perforation, stroke, urgent or emergent revascularization	1 day

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Chang Gung Memorial Hospital; Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Hsien-Li Kao, MD, National Taiwan University Hospital

Publications and helpful links

General Publications

• 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 Occlusions Registry. J Am Coll Cardiol. 2012 Mar 13;59(11):991-7. doi: 10.1016/j.jacc.2011.12.007.
• 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 total occlusions: 2019 consensus document from the EuroCTO Club. EuroIntervention. 2019 Jun 20;15(2):198-208. doi: 10.4244/EIJ-D-18-00826.
• Rossello X, Pujadas S, Serra A, Bajo E, Carreras F, Barros A, Cinca J, Pons-Llado G, Vaquerizo B. Assessment of Inducible Myocardial Ischemia, Quality of Life, and Functional Status After Successful Percutaneous Revascularization in Patients With Chronic Total Coronary Occlusion. Am J Cardiol. 2016 Mar 1;117(5):720-6. doi: 10.1016/j.amjcard.2015.12.001. Epub 2015 Dec 12.
• Chen S, Karmpaliotis D, Redfors B, Shlofmitz E, Ben-Yehuda O, Crowley A, Mehdipoor G, Puskas JD, Kandzari DE, Banning AP, Morice MC, Taggart DP, Sabik JF 3rd, Serruys PW, Kappetein AP, Stone GW. Does an occluded RCA affect prognosis in patients undergoing PCI or CABG for left main coronary artery disease? Analysis from the EXCEL trial. EuroIntervention. 2019 Aug 9;15(6):e531-e538. doi: 10.4244/EIJ-D-19-00263.
• Wu EB, Brilakis ES, Mashayekhi K, Tsuchikane E, Alaswad K, Araya M, Avran A, Azzalini L, Babunashvili AM, Bayani B, Behnes M, Bhindi R, Boudou N, Boukhris M, Bozinovic NZ, Bryniarski L, Bufe A, Buller CE, Burke MN, Buttner A, Cardoso P, Carlino M, Chen JY, Christiansen EH, Colombo A, Croce K, de Los Santos FD, de Martini T, Dens J, di Mario C, Dou K, Egred M, Elbarouni B, ElGuindy AM, Escaned J, Furkalo S, Gagnor A, Galassi AR, Garbo R, Gasparini G, Ge J, Ge L, Goel PK, Goktekin O, Gonzalo N, Grancini L, Hall A, Hanna Quesada FL, Hanratty C, Harb S, Harding SA, Hatem R, Henriques JPS, Hildick-Smith D, Hill JM, Hoye A, Jaber W, Jaffer FA, Jang Y, Jussila R, Kalnins A, Kalyanasundaram A, Kandzari DE, Kao HL, Karmpaliotis D, Kassem HH, Khatri J, Knaapen P, Kornowski R, Krestyaninov O, Kumar AVG, Lamelas PM, Lee SW, Lefevre T, Leung R, Li Y, Li Y, Lim ST, Lo S, Lombardi W, Maran A, McEntegart M, Moses J, Munawar M, Navarro A, Ngo HM, Nicholson W, Oksnes A, Olivecrona GK, Padilla L, Patel M, Pershad A, Postu M, Qian J, Quadros A, Rafeh NA, Ramunddal T, Prakasa Rao VS, Reifart N, Riley RF, Rinfret S, Saghatelyan M, Sianos G, Smith E, Spaedy A, Spratt J, Stone G, Strange JW, Tammam KO, Thompson CA, Toma A, Tremmel JA, Trinidad RS, Ungi I, Vo M, Vu VH, Walsh S, Werner G, Wojcik J, Wollmuth J, Xu B, Yamane M, Ybarra LF, Yeh RW, Zhang Q. Global Chronic Total Occlusion Crossing Algorithm: JACC State-of-the-Art Review. J Am Coll Cardiol. 2021 Aug 24;78(8):840-853. doi: 10.1016/j.jacc.2021.05.055.
• 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: 10.1161/CIRCINTERVENTIONS.117.005124.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): December 31, 2034

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Coronary artery disease; Coronary intervention; CTO; Coronary Chronic Total Occlusion; Collateral channel
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 202409095RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No