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Percutaneous Coronary RevascularisationULTRA-CTONCT04780971

Use of Physiology to Evaluate Procedural Result After PCI CTO

A study testing post-PCI Pd/Pa in people with Percutaneous Coronary Revascularisation and Complex Coronary Lesion, run by Isala at 2 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
post-PCI Pd/Pa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesNetherlands
Study dates
21 Jul 2021to Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 1) Contra-indication for adenosine.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Maarten van Leeuwen, PhD contact

0031 38 424 2374

m.a.h.van.leeuwen@isala.nl

Netherlands2 sites, 2 recruiting

  • Radboud UMC

    Nijmegen

    Alexander Griffioen, MD, MSc, alexander.griffioen@radboudumc.nl

    Robert Jan van Geuns, MD, PhD, robertjan.vangeuns@radboudumc.nl

    Not yet recruiting

  • Isala

    Zwolle, 8025 AB

    Maarten Van Leeuwen, MD, PhD, 0031 38 424 2374, m.a.h.van.leeuwen@isala.nl

    Tom Meijers, MD, MSc, 0031 38 424 2374, t.a.meijers@isala.nl

    Recruiting

Other trials in Netherlands

About this study

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.

Read the detailed description

ULTRA-CTO is a prospective multicentre non-randomised investigator-initiated trial designed to enrol 200 subjects with an indication for PCI CTO.

The main objective of the study is to evaluate both the value of post-PCI RFR and post-PCI FFR for detecting suboptimal stent result (SSR).

After angiographically successful CTO PCI, intra-coronary physiologic assessment (RFR, FFR, coronary flow reserve (CFR) and index of microcirculatory resistance (IMR)) of the CTO vessel will be performed. Additional OCT will be performed directly or during a staged procedure within 4 ± 2 weeks when indicated (i.e. high contrast use, procedural duration, major dissection or other safety reasons according to the operator).

When intra-coronary physiologic assessment or OCT is not possible at all, the patients will not be included in the study.

When the operator decides to optimize the stent result (post-dilation or additional stenting), based on the OCT and/or physiology, post-PCI RFR and FFR should be repeated. For patients undergoing a clinically indicated FFR of a remaining intermediate stenosis (angiographically 30-90%) in a non-CTO vessel or major side branch of the CTO vessel within 4 weeks after the index procedure, intra-coronary physiologic assessment (RFR, FFR, CFR and IMR) will be repeated in the CTO vessel for exploratory objectives

At 4 ± 2 weeks follow-up, the occurrence of cardiovascular events and clinical classification will be assessed for secondary objectives

Being tested
post-PCI Pd/Pa
Keywords
percutaneous coronary intervention, chronic total occlusion, intra-coronary physiology, optical coherence tomography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • post-PCI Pd/PaDiagnostic test

    Also called Post-PCI RFR, Post-PCI CFR, Post-PCI IMR, Post-PCI FFR

    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 groups in NCT04780971
Study groupRoleWhat they receive
Post-PCI intra-coronary physiological and OCT measurementsOtherAfter angiographically successful CTO PCI, intra-coronary physiologic assessment (RFR, FFR, CFR and IMR) and OCT of the CTO vessel will be performed directly. OCT may als be performed during a staged procedure within 4 ± 2 weeks after the index procedure when clinically indicated.
Receives: Diagnostic Test: post-PCI Pd/Pa

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Index procedure (or staged procedure if indicated).

Secondary outcomes (8)

  1. Seattle Angina Questionnaire (SAQ) score at follow-up

    Seattle Angina Questionnaire (SAQ) score at follow-up

    Measured: 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

    Measured: 4± 2 weeks

  3. Canadian Cardiovascular Society (CCS) classification at follow-up

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

    Measured: 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

    Measured: 4± 2 weeks

  5. The predictive value of the RFR and FFR gradient across the stented segment with regard to SSR in CTO patients.

    The predictive value of the RFR and FFR gradient across the stented segment with regard to SSR in CTO patients.

    Measured: Index procedure (or staged procedure if indicated).

  6. The correlation between positive RFR (≤0.89) and positive FFR (≤0.80) with regard to SSR following angiographically satisfactory CTO PCI.

    The correlation between positive RFR (≤0.89) and positive FFR (≤0.80) with regard to SSR following angiographically satisfactory CTO PCI.

    Measured: Index procedure (or staged procedure if indicated).

  7. The correlation between post-PCI physiology (OCT, RFR, FFR, CFR, IMR) and suboptimal stent result (SSR) with anginal complaints (SAQ score), NYHA and CCS classification and MACE at follow-up

    The correlation between post-PCI physiology (OCT, RFR, FFR, CFR, IMR) and suboptimal stent result (SSR) with anginal complaints (SAQ score), NYHA and CCS classification and MACE at follow-up.

    Measured: Index procedure (or staged procedure if indicated) until 4± 2 weeks follow-up

  8. The impact on physician-decision making based on OCT and physiology findings

    The impact on physician-decision making based on OCT and physiology findings

    Measured: Index procedure (or staged procedure if indicated).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2021
  2. Study start21 Jul 2021
  3. Primary completionMay 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04780971
Sponsor's protocol ID
9346
Acronym
ULTRA-CTO
Status last verified
Feb 2025
First submitted
6 Jan 2021
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Griffioen AM, Meijers TA, Roolvink V, van der Heijden DJ, Volleberg RHJA, van Wely M, van Royen N, van Geuns RJ, van Leeuwen M. Use of physioLogy to evaluaTe procedural Result After percutaneous coronary intervention of Chronic Total Occlusion (ULTRA-CTO): protocol for a prospective, single-arm, multicentre, exploratory study. BMJ Open. 2025 Nov 27;15(11):e108995. doi: 10.1136/bmjopen-2025-108995.

    PubMed 41309467

Questions about this trial

What is this clinical trial studying?

A study testing post-PCI Pd/Pa in people with Percutaneous Coronary Revascularisation and Complex Coronary Lesion, run by Isala at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maarten van Leeuwen, PhD (0031 38 424 2374, m.a.h.van.leeuwen@isala.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04780971, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.

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