TRIO CTO (Taiwan Research Initiative on Coronary Total Occlusion)

NCT06917378 | Recruiting

• 1 other identifier: 202409095RINC
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Chronic Total Occlusion (CTO)

Keywords

CTO; Coronary Chronic Total Occlusion; Coronary artery disease; Coronary intervention; Collateral channel

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Number of participants with periprocedural myocardial infarction

  1 day

• Number of participants with periprocedural complications

  1 day

Study Arms (3)

Successful CTO intervention

Successful CTO intervention, subgrouped by strategies, ex. antegrade or retrograde approach

Procedure: Percutaneous coronary intervention of coronary chronic total occlusion

Failed CTO intervention

Failed CTO intervention, subgrouped by strategies, ex. antegrade or retrograde approach

Procedure: Percutaneous coronary intervention of coronary chronic total occlusion

No CTO intervention

CTO was not intervened

Interventions

Percutaneous coronary intervention of coronary chronic total occlusion PROCEDURE

Coronary CTO was identified by coronary angiography, and its revascularization was attempted by either antegrade, retrograde or both approach.

Also known as: PCI to CTO

Failed CTO intervention; Successful CTO intervention

Eligibility Criteria

• Age: 20 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Chang Gung Memorial Hospital: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator

Study Sites (3)

Chang Gung Memorial Hospital

New Taipei City, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

Related Publications (6)

• 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.

  PMID: 26747733 BACKGROUND

• 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.

  PMID: 31186220 BACKGROUND

• 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.

  PMID: 22402070 BACKGROUND

• 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.

  PMID: 34412818 BACKGROUND

• 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.

  PMID: 30636678 BACKGROUND

• 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.

  PMID: 29311284 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Hsien-Li Kao, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chih Fan Yeh

CONTACT

+8862-23123456; nicholas.yeh@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hsien-Li Kao, Director of Cardiovascular Center

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: April 8, 2025
• Study Start: January 1, 2017
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): December 31, 2034
• Last Updated: December 18, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)