Status:
ACTIVE_NOT_RECRUITING
Invest-CTO PCI Trial
Lead Sponsor:
Haukeland University Hospital
Collaborating Sponsors:
Golden Jubilee National Hospital
Conditions:
Chronic Total Occlusion of Coronary Artery
Angina Pectoris
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04774913
Start Date
December 8 2021
End Date
October 1 2026
Last Update
November 21 2025
Active Locations (5)
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1
Columbia University Medical Center/ NewYork Presbyterian Hospital
New York, New York, United States, 10032
2
Haukeland University Hospital
Bergen, Bergen, Norway, 5021
3
Golden Jubilee National Hospital
Glasgow, Glasgow, United Kingdom, G814DY
4
Bristol Health
Bristol, United Kingdom, 06010