Angina Pectoris, Chronic Total Occlusion of Coronary Artery, PROM, Quality of Life
Conditions
Keywords
Percutaneous coronary intervention
Brief summary
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
Interventions
PROCEDUREChronic total occlusion(CTO) percutaneous coronary intervention (PCI)
CTO PCI completed as a two step procedure with an initial planned CTO modification and a completion procedure after 8-12 weeks
Sponsors
Golden Jubilee National Hospital
Haukeland University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, single arm, international, multicenter study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness | Up to 12 weeks | 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 \[TVR\] |
| Compositie safety endpoint | 30 days post procedure | Death, myocardial infarction and procedural related complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compositie safety endpoint | 30 days post procedure | Death, myocardial infarction and procedural related complications |
| Composite Clinical endpoint | 30 days, 3 & 12 months | Cardiac death, MI , cardiovascular hospitalization and target vessel revascularization. |
| CTO PCI technical success | At the end of staged CTO PCI completion procedure and within 3 months | Technical success is restoration of TIMI \>=2 antegrade flow with \<30% residual diameter stenosis within the CTO segment |
| Seattle angina questionnaire (SAQ7) | Baseline, 3 & 12 months | 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. |
| Patient related outcome measures (PROM) | Through study completion, an average of 15 months. | Qualitative interviews |
| European Quality of Life-5 Dimensions | Baseline, 3 and 12 months | 5 item measure of mobility, self-care, usual activity, pain or discomfort, and anxiety or depression . Score 0-100, where high score better. |
| CTO PCI investment procedural success | 30 days post procedure | Investment complete technical success |
Countries
Norway, United Kingdom, United States
Outcome results
None listed