Planned investment procedure for treating chronic total occlusion in coronary arteries
Invest-CTO: Effectiveness and Safety of a Planned Investment Procedure in High-Risk CTO PCI
This study is testing a new planned procedure for treating blocked coronary arteries to see if it can make the treatment safer and more successful for patients with chronic total occlusion.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Haukeland University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (New York, New York and 2 other locations) |
| Trial ID | NCT04774913 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a planned investment procedure for patients with chronic total occlusion (CTO) of coronary arteries. The study aims to determine if this approach can enhance patient safety, improve cumulative procedure success rates, and provide a better overall patient experience. By comparing outcomes from initial and staged completion percutaneous coronary interventions (PCI), the researchers hope to establish a more efficient treatment protocol for high-risk CTO cases. The trial will involve patients who meet specific eligibility criteria and will be conducted at multiple renowned medical centers.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with high-risk chronic total occlusion who can provide informed consent and comply with the study protocol.
Not a fit: Patients with non-high risk CTO or those with contraindications to dual antiplatelet therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective treatments for patients with chronic total occlusion of coronary arteries.
How similar studies have performed: While similar approaches have been reported in CTO PCI registries, this specific planned investment procedure has not been extensively tested in clinical trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York and 2 other locations
- Columbia University Medical Center/ NewYork Presbyterian Hospital — New York, New York, United States (Not_yet_recruiting)
- Haukeland University Hospital — Bergen, Norway (Recruiting)
- Golden Jubilee National Hospital — Glasgow, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Margaret B Mcentegart, PhD — Golden Jubilee National Hospital
- Study coordinator: Anja Øksnes, MD
- Email: anao@helse-bergen.no
- Phone: +4755975000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.