NCT04774913Active, not recruiting
Invest-CTO PCI Trial
Invest-CTO: Effectiveness and Safety of a Planned Investment Procedure in High-Risk CTO PCI
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 17 Feb 2021
- Start date
- 8 Dec 2021
- Primary completion date
- 9 Oct 2025
- Lead sponsor
- Haukeland University Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT04774913
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 8 Dec 2021 to the primary completion date, 9 Oct 2025
- 5 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contra-indication to dual antiplatelet therapy
- Prior radiation skin injury
Other
- 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
- Pregnancy
- Lack of informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bristol Health Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Golden Jubilee National Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| St. George's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Haukeland University Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
| Columbia University Medical Center/ NewYork Presbyterian Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.