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Clinical Trials in the Netherlands / NCT04780971
Recruiting Not applicable

Use of Physiology to Evaluate Procedural Result After PCI CTO

NCT04780971 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Isala
Phase
Not applicable
Started
2021-07-21
Last updated
2025-02-19

Condition(s) studied

Percutaneous Coronary RevascularisationComplex Coronary Lesion

Investigational drug(s) / intervention(s)

post-PCI Pd/Pa

post-PCI Pd/Pa: After angiographically successful CTO PCI, intra-coronary physiologic assessment (RFR, FFR, CFR and IMR) and subsequent OCT of the CTO vessel will be performed. OCT may also be performed during a staged procedure when clinically indicated.

Study summary

ULTRA-CTO is a prospective multicentre non-randomised investigator-initiated trial designed to enrol 200 subjects with an indication for percutaneous coronary intervention (PCI) of chronic total occluded (CTO) coronary artery.

The main objective of the study is to assess the predictive value of post-PCI resting full-cycle ratio (RFR) and fractional flow reserve (FFR) with regard to Fractional flow reserve (SSR) in CTO patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Radboud UMC Nijmegen Netherlands Not Yet Recruiting
Isala Zwolle Netherlands Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04780971 on ClinicalTrials.gov ↗ ← All trials in the Netherlands