Clinical trial NCT06917378: TRIO CTO (Taiwan Research Initiative on Coronary Total Occlusion)
Official title: The Multicenter Study to Evaluate Clinical and Angiographic Factors in Patients With Coronary Artery Chronic Total Occlusion in Taiwan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Total Occlusion (CTO)
Keywords: CTO
Coronary Chronic Total Occlusion
Coronary artery disease
Coronary intervention
Collateral channel
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
name: Taipei Veterans General Hospital, Taiwan
First posted: 2025-04-08
Enrollment: 5000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with technical success of CTO revascularization
timeFrame: 1 day
measure: Number of participants with collateral channel tracking success
timeFrame: 1 day
measure: Number of participants with major adverse cerebral cardiovascular events
timeFrame: 5 years
Secondary outcomes:
measure: Number of participants with periprocedural myocardial infarction
timeFrame: 1 day
measure: Number of participants with periprocedural complications
timeFrame: 1 day
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Hsien-Li Kao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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