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Use of Physiology to Evaluate Procedural Result After PCI CTO

ConditionsPercutaneous Coronary RevascularisationComplex Coronary Lesion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIsala

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years and older.

Angiographically successful PCI CTO without any remaining lesion at least 30% proximal to the stented segment.

Possibility to perform physiologic measurements and OCT of sufficient quality.

Patients willing and capable to provide written informed consent.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • post-PCI Pd/Pa

    Diagnostic test

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Post-PCI intra-coronary physiological and OCT measurementsOther 1 intervention

Trial outcomes

Primary outcomes

1

The AUC of post-PCI RFR compared to the AUC of post-PCI FFR with regard to SSR.

The AUC of post-PCI RFR compared to the AUC of post-PCI FFR with regard to SSR.

Time frame
Index procedure (or staged procedure if indicated).

Secondary outcomes

1

Seattle Angina Questionnaire (SAQ) score at follow-up

Seattle Angina Questionnaire (SAQ) score at follow-up

Time frame
4± 2 weeks
2

New York Heart Association (NYHA) classification at follow-up

New York Heart Association (NYHA) classification (I, II, III or IV) at follow-up

Time frame
4± 2 weeks
3

Canadian Cardiovascular Society (CCS) classification at follow-up

Canadian Cardiovascular Society (CCS) classification (I, II, III, IV) at follow-up

Time frame
4± 2 weeks
4

Occurrence of the composite endpoint of all-cause mortality, myocardial infarction and any coronary revascularization (MACE) at follow-up

Occurrence of the composite endpoint of all-cause mortality, myocardial infarction and any coronary revascularization (MACE) at follow-up

Time frame
4± 2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Isala

Lead sponsor

Abbott

Collaborator

Source ClinicalTrials.gov
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