TRIO CTO (Taiwan Research Initiative on Coronary Total Occlusion)

Recruiting

• Conditions: Chronic Total Occlusion (CTO)

• Registration Number: NCT06917378
• Lead Sponsor: National Taiwan University Hospital

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.

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 Timeline

• Study Start: 2017-01-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2025-03-31
• Study First Posted: 2025-04-08
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Primary Completion: 2034-12-31
• Study Completion: 2034-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with technical success of CTO revascularization	1 day	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
Number of participants with collateral channel tracking success	1 day	retrograde guidewire crossing the CC to reach the distal cap of CTO segment.
Number of participants with major adverse cerebral cardiovascular events	5 years	Death, CV death, myocardial infarction, stroke, repeat revascularization

Secondary Outcome Measures

Name	Time	Method
Number of participants with periprocedural myocardial infarction	1 day	Confirmed by
Number of participants with periprocedural complications	1 day	Periprocedural myocardial infarction, vessel perforation, stroke, urgent or emergent revascularization

Trial Locations

Locations (3)

Chang Gung Memorial Hospital; 🇨🇳 New Taipei City, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan