Use of Physiology to Evaluate Procedural Result After PCI CTO (ULTRA-CTO)

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.

Study Overview

• Status: Recruiting
• Conditions: Percutaneous Coronary Revascularisation; Complex Coronary Lesion
• Intervention / Treatment: Diagnostic test: post-PCI Pd/Pa

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

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maarten van Leeuwen, PhD; Phone Number: 0031 38 424 2374; Email: m.a.h.van.leeuwen@isala.nl

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • Not yet recruiting
    • Radboud UMC
    • Contact: Alexander Griffioen, MD, MSc; Email: alexander.griffioen@radboudumc.nl
    • Contact: Robert Jan van Geuns, MD, PhD; Email: robertjan.vangeuns@radboudumc.nl
    • Principal Investigator: Robert Jan van Geuns, MD, PhD
    • Sub-Investigator: Alexander Griffioen, MD, MSc
  • Zwolle, Netherlands, 8025 AB
    • Recruiting
    • Isala
    • Principal Investigator: Maarten Van Leeuwen, MD, PhD
    • Contact: Maarten Van Leeuwen, MD, PhD; Phone Number: 0031 38 424 2374; Email: m.a.h.van.leeuwen@isala.nl
    • Contact: Tom Meijers, MD, MSc; Phone Number: 0031 38 424 2374; Email: t.a.meijers@isala.nl
    • Sub-Investigator: Tom Meijers, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Post-PCI intra-coronary physiological and OCT measurements; After 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.	Diagnostic test: 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.; Other Names: Post-PCI RFR; Post-PCI CFR; Post-PCI IMR; Post-PCI FFR; Post-PCI OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Index procedure (or staged procedure if indicated).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seattle Angina Questionnaire (SAQ) score at follow-up	Seattle Angina Questionnaire (SAQ) score at follow-up	4± 2 weeks
New York Heart Association (NYHA) classification at follow-up	New York Heart Association (NYHA) classification (I, II, III or IV) at follow-up	4± 2 weeks
Canadian Cardiovascular Society (CCS) classification at follow-up	Canadian Cardiovascular Society (CCS) classification (I, II, III, IV) at follow-up	4± 2 weeks
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	4± 2 weeks
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.	Index procedure (or staged procedure if indicated).
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.	Index procedure (or staged procedure if indicated).
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.	Index procedure (or staged procedure if indicated) until 4± 2 weeks follow-up
The impact on physician-decision making based on OCT and physiology findings	The impact on physician-decision making based on OCT and physiology findings	Index procedure (or staged procedure if indicated).

Collaborators and Investigators

• Sponsor: Isala
• Collaborators: Abbott
• Investigators: Principal Investigator: Maarten Van Leeuwen, PhD, Isala Zwolle

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 15, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; chronic total occlusion; intra-coronary physiology; optical coherence tomography
• Other Study ID Numbers: 9346

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No