Invest-CTO: Effectiveness and Safety of a Planned Investment Procedure in High-Risk CTO PCI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 5
- Primary Endpoint
- Compositie safety endpoint
Study Overview
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
- 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Invest CTO PCI
A pre-planned two staged procedure in high-risk CTO PCI
Intervention: Chronic total occlusion(CTO) percutaneous coronary intervention (PCI) (Procedure)
Outcomes
Primary Outcomes
Compositie safety endpoint
Time Frame: 30 days post procedure
Death, myocardial infarction and procedural related complications
Effectiveness
Time Frame: 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 \[TVR\]
Secondary Outcomes
- Seattle angina questionnaire (SAQ7)(Baseline, 3 & 12 months)
- CTO PCI technical success(At the end of staged CTO PCI completion procedure and within 3 months)
- CTO PCI investment procedural success(30 days post procedure)
- CTO PCI investment procedural success(30 days post procedure)
- CTO PCI technical success(At the end of staged CTO PCI completion procedure and within 3 months)
- Seattle angina questionnaire (SAQ7)(Baseline, 3 & 12 months)
- Compositie safety endpoint(30 days post procedure)
- Composite Clinical endpoint(30 days, 3 & 12 months)
- European Quality of Life-5 Dimensions(Baseline, 3 and 12 months)
- Patient related outcome measures (PROM)(Through study completion, an average of 15 months.)