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 1. A planned investment procedure in the treatment of CTOs will be associated with improved patient safety 2. A planned investment procedure will be associated with improved cumulative procedure success rates 3. A planned two stage procedure will be associated with improved patient experience
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
CTO PCI completed as a two step procedure with an initial planned CTO modification and a completion procedure after 8-12 weeks
Columbia University Medical Center/ NewYork Presbyterian Hospital
New York, New York, United States
Haukeland University Hospital
Bergen, Bergen, Norway
Golden Jubilee National Hospital
Glasgow, Glasgow, United Kingdom
Bristol Health
Bristol, United Kingdom
St George´s Hospital
London, United Kingdom
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 \[TVR\]
Time frame: Up to 12 weeks
Compositie safety endpoint
Death, myocardial infarction and procedural related complications
Time frame: 30 days post procedure
CTO PCI technical success
Technical success is restoration of TIMI \>=2 antegrade flow with \<30% residual diameter stenosis within the CTO segment
Time frame: At the end of staged CTO PCI completion procedure and within 3 months
CTO PCI investment procedural success
Investment complete technical success
Time frame: 30 days post procedure
Compositie safety endpoint
Death, myocardial infarction and procedural related complications
Time frame: 30 days post procedure
Composite Clinical endpoint
Cardiac death, MI , cardiovascular hospitalization and target vessel revascularization.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 & 12 months
Patient related outcome measures (PROM)
Qualitative interviews
Time frame: Through study completion, an average of 15 months.
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