Invest-CTO PCI Trial

Study Overview
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Brief Summary
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Following unsuccessful CTO crossing a CTO modification procedure is sometimes performed. CTO PCI registries where plaque modification has been performed in some patients, report this to be safe, and associated with higher success rates at subsequent attempts. It has never been investigated whether a planned investment procedure, with an intention that both the initial and staged completion PCI are of shorter duration, could improve safety and efficacy. The investigators hypothesize that A planned investment procedure in the treatment of CTOs will be associated with improved patient safety A planned investment procedure will be associated with improved cumulative procedure success rates A planned two stage procedure will be associated with improved patient experience

Official Title
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Invest-CTO: Effectiveness and Safety of a Planned Investment Procedure in High-Risk CTO PCI

Conditions
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Chronic Total Occlusion of Coronary Artery, Angina Pectoris, Quality of Life, PROM

Intervention / Treatment
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* Procedure: Chronic total occlusion(CTO) percutaneous coronary intervention (PCI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide written informed consent Comply with the procedural and study follow-up schedule Planned CTO PCI in accordance with the European and American appropriateness criteria. CTO defined as high-risk Exclusion Criteria: Non-high risk CTO Occlusion within a stent Flush aorto-ostial occlusion of RCA and Left Main (LMS) Limited arterial access precluding repeat procedure Baseline non invasive testing showing non-viable target vessel territory Contra-indication to dual antiplatelet therapy Pregnancy Prior radiation skin injury Lack of informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, single arm, international, multicenter study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Invest CTO PCI<br>A pre-planned two staged procedure in high-risk CTO PCI | Procedure: Chronic total occlusion(CTO) percutaneous coronary intervention (PCI)<br>* CTO PCI completed as a two step procedure with an initial planned CTO modification and a completion procedure after 8-12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | CTO PCI Procedural success, Complete technical success plus the absence of an in-hospital major adverse cardiovascular event (MACE; death, MI, or clinically driven target vessel revascularization [TVR] | Up to 12 weeks | 
| Compositie safety endpoint | Death, myocardial infarction and procedural related complications | 30 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CTO PCI technical success | Technical success is restoration of TIMI >=2 antegrade flow with <30% residual diameter stenosis within the CTO segment | At the end of staged CTO PCI completion procedure and within 3 months | 
| CTO PCI investment procedural success | Investment complete technical success | 30 days post procedure | 
| Composite Clinical endpoint | Cardiac death, MI , cardiovascular hospitalization and target vessel revascularization. | 30 days, 3 & 12 months | 
| European Quality of Life-5 Dimensions | 5 item measure of mobility, self-care, usual activity, pain or discomfort, and anxiety or depression . Score 0-100, where high score better. | Baseline, 3 and 12 months | 
| Seattle angina questionnaire (SAQ7) | 3 domain score of physical limitation (SAQ7-PL), angina frequency (SAQ7-AF) and quality of life (SAQ7-QL). Score 0-100, where high score better. | Baseline, 3 & 12 months | 
| Patient related outcome measures (PROM) | Qualitative interviews | Through study completion, an average of 15 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous coronary intervention