Evaluating heart procedure results using advanced imaging techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Isala
  Zwolle, Netherlands Recruiting
• Radboud UMC
  Nijmegen, Netherlands Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.