Evaluating heart procedure results using advanced imaging techniques
Use of Physiology to Evaluate Procedural Result After PCI CTO
This study is testing if new heart imaging techniques can help doctors better understand how well a stent works after a procedure for blocked arteries in people with chronic total occlusion.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Isala Academic / other |
| Locations | 2 sites (Nijmegen and 1 other locations) |
| Trial ID | NCT04780971 on ClinicalTrials.gov |
What this trial studies
The ULTRA-CTO trial is a prospective multicentre trial aimed at enrolling 200 patients who require percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) of coronary arteries. The study focuses on assessing the effectiveness of post-PCI physiological measurements, specifically resting full-cycle ratio (RFR) and fractional flow reserve (FFR), in predicting suboptimal stent results. Participants will undergo intra-coronary physiological assessments and optical coherence tomography (OCT) to evaluate the success of their procedures. Follow-up assessments will track cardiovascular events and clinical outcomes over a period of 4 ± 2 weeks.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone successful PCI for CTO without significant remaining lesions.
Not a fit: Patients who have contraindications for adenosine or cannot undergo the necessary physiological measurements will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of assessing the success of PCI procedures, leading to better patient outcomes.
How similar studies have performed: Previous studies have shown promise in using physiological assessments and imaging techniques in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years and older. 2. Angiographically successful PCI CTO without any remaining lesion at least 30% proximal to the stented segment. 3. Possibility to perform physiologic measurements and OCT of sufficient quality. 4. Patients willing and capable to provide written informed consent. Exclusion Criteria: 1\) Contra-indication for adenosine.
Where this trial is running
Nijmegen and 1 other locations
- Radboud UMC — Nijmegen, Netherlands (Not_yet_recruiting)
- Isala — Zwolle, Netherlands (Recruiting)
Study contacts
- Principal investigator: Maarten Van Leeuwen, PhD — Isala Zwolle
- Study coordinator: Maarten van Leeuwen, PhD
- Email: m.a.h.van.leeuwen@isala.nl
- Phone: 0031 38 424 2374
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.