Invest-CTO PCI Trial
Running, not enrolling · Not applicable
Conditions studied: Chronic Total Occlusion of Coronary Artery, Angina Pectoris, Quality of Life, PROM
In brief
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
Key facts
- Study ID
- NCT04774913
- Run by
- Haukeland University Hospital
- People needed
- 200
- Starts
- 2021-12-08
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2025-11-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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