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

• ClinicalTrials.gov Identifier: NCT04780971
• Recruitment Status: Recruiting
• First Posted: March 4, 2021
• Last Update Posted: September 5, 2021
• Sponsor: Maatschap Cardiologie Zwolle
• Collaborators: Abbott; Diagram B.V.
• Information provided by (Responsible Party): Maatschap Cardiologie Zwolle

Study Description

Brief 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 and who have at least one intermediate (angiographically 30-90%) stenosis in a non-CTO vessel or major side branch of the CTO vessel with a diameter of at least 2 mm.

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.

Condition or disease	Intervention/treatment	Phase
Percutaneous Coronary Revascularisation; Complex Coronary Lesion	Diagnostic Test: post-PCI Pd/Pa	Not Applicable

Detailed Description:

ULTRA-CTO is a prospective multicentre non-randomised investigator-initiated trial designed to enrol 200 subjects with an indication for PCI CTO and who have at least one intermediate (angiographically 30-90%) stenosis in a non-CTO vessel or major side branch of the CTO vessel with a diameter of at least 2mm.

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) in the acute phase and the stability of these measurements over time.

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 directly. A staged procedure including several measurements is planned at 4 ± 2 weeks after the index procedure. These measurements include same intra-coronary physiologic measurements as performed at index procedure and optical coherence tomography (OCT) imaging of the stented segment in the CTO target vessel.

Prior to the staged procedure occurrence of cardiovascular events and clinical classification will be assessed.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Use of Physiology to Evaluate Procedural Result After PCI CTO
• Actual Study Start Date: July 21, 2021
• Estimated Primary Completion Date: May 2024
• Estimated Study Completion Date: June 2024

Arms and Interventions

Arm

Intervention/treatment

Post-PCI intra-coronary physiological and OCT measurements; After angiographically successful CTO PCI, intra-coronary physiologic assessment (RFR, FFR, CFR and IMR) of the CTO vessel will be performed directly. A staged procedure including several measurements is planned at 4 ± 2 weeks after the index procedure. These measurements consists of the same intra-coronary physiologic assessments at index procedure and OCT imaging of the stented segment in the CTO target vessel.

Diagnostic Test: post-PCI Pd/Pa; After angiographically successful CTO PCI, intra-coronary physiologic assessment (RFR, FFR, CFR and IMR) of the CTO vessel will be performed directly. A staged procedure including several measurements is planned at 4 ± 2 weeks after the index procedure. These measurements consists of the same intra-coronary physiologic assessments at index procedure and OCT imaging of the stented segment in the CTO target vessel.; Other Names: Post-PCI RFR; Post-PCI CFR; Post-PCI IMR; Post-PCI FFR; Post-PCI OCT

Outcome Measures

Primary Outcome Measures :

1. The AUC of post-PCI RFR compared to the AUC of post-PCI FFR with regard to SSR. [ Time Frame: Index and 4 weeks ]
   The AUC of post-PCI RFR compared to the AUC of post-PCI FFR with regard to SSR.

Secondary Outcome Measures :

1. Seattle Angina Questionnaire (SAQ) score at 4 weeks [ Time Frame: 4 weeks ]
   Seattle Angina Questionnaire (SAQ) score at 4 weeks
2. New York Heart Association (NYHA) classification at 4 weeks [ Time Frame: 4 weeks ]
   New York Heart Association (NYHA) classification (I, II, III or IV) at 4 weeks
3. Canadian Cardiovascular Society (CCS) classification at 4 weeks [ Time Frame: 4 weeks ]
   Canadian Cardiovascular Society (CCS) classification (I, II, III, IV) at 4 weeks
4. Occurrence of target lesion revascularization (TLR) at 4 weeks [ Time Frame: 4 weeks ]
   Occurrence of target lesion revascularization (TLR) at 4 weeks
5. Occurrence of stent thrombosis (ST) at 4 weeks [ Time Frame: 4 weeks ]
   Occurrence of stent thrombosis (ST) at 4 weeks
6. Occurrence of target vessel failure (TVF) at 4 weeks [ Time Frame: 4 weeks ]
   Occurrence of target vessel failure (TVF) at 4 weeks
7. Occurrence of the composite endpoint of all-cause mortality, myocardial infarction and any coronary revascularization (MACE) at 4 weeks [ Time Frame: 4 weeks ]
   Occurrence of the composite endpoint of all-cause mortality, myocardial infarction and any coronary revascularization (MACE) at 4 weeks
8. The predictive value of the RFR and FFR gradient across the stented segment with regard to SSR in CTO patients. [ Time Frame: Index PCI CTO until staged procedure at 4 weeks ]
   The predictive value of the RFR and FFR gradient across the stented segment with regard to SSR in CTO patients.
9. The correlation of post-PCI RFR and -FFR with SSR at 4 weeks. [ Time Frame: During staged procedure (4 weeks after index CTO PCI) ]
   The correlation of post-PCI RFR and -FFR with SSR at 4 weeks.
10. The change in resting full-cycle ratio (RFR) over a period of 4 weeks after CTO PCI. [ Time Frame: Index PCI CTO until staged procedure at 4 weeks ]
    The change in resting full-cycle ratio (RFR) over a period of 4 weeks after CTO PCI.
11. The change in fractional flow reserve (FFR) over a period of 4 weeks after CTO PCI. [ Time Frame: Index PCI CTO until staged procedure at 4 weeks ]
    The change in fractional flow reserve (FFR) over a period of 4 weeks after CTO PCI.
12. The change in pressure-distal / pressure-aorta (Pd/Pa) over a period of 4 weeks after CTO PCI. [ Time Frame: Index PCI CTO until staged procedure at 4 weeks ]
    The change in pressure-distal / pressure-aorta = ratio of mean resting distal coronary pressure to aortic pressure (Pd/Pa) over a period of 4 weeks after CTO PCI.
13. The change in coronary flow reserve (CFR) over a period of 4 weeks after CTO PCI. [ Time Frame: Index PCI CTO until staged procedure at 4 weeks ]
    The change in coronary flow reserve (CFR) over a period of 4 weeks after CTO PCI.
14. The correlation between positive RFR (≤0.89) and positive FFR (≤0.80) following angiographically satisfactory CTO PCI. [ Time Frame: During index CTO PCI ]
    The correlation between positive RFR (≤0.89) and positive FFR (≤0.80) following angiographically satisfactory CTO PCI.
15. The incidence and change of microvascular dysfunction as assessed by IMR over a period of 4 weeks after CTO PCI. [ Time Frame: Index PCI CTO until staged procedure at 4 weeks ]
    The incidence and change of microvascular dysfunction as assessed by IMR over a period of 4 weeks after CTO PCI.
16. The correlation between post-PCI physiology (OCT, RFR, FFR, CFR, IMR) and suboptimal stent result (SSR) with anginal complaints (SAQ score) at 4 weeks. [ Time Frame: During staged procedure (4 weeks after index CTO PCI) ]
    The correlation between post-PCI physiology (OCT, RFR, FFR, CFR, IMR) and suboptimal stent result (SSR) with anginal complaints (SAQ score) at 4 weeks.
17. The impact on physician-decision making based on OCT and physiology findings at 4 weeks. [ Time Frame: During staged procedure (4 weeks after index CTO PCI) ]
    The impact on physician-decision making based on OCT and physiology findings at 4 weeks.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. Age 18 years and older.
2. Presence of at least one intermediate (angiographically 30-90%) stenosis in the non-CTO vessel or major side branch of the CTO vessel with diameter of at least 2mm, for which FFR is clinically indicated.
3. Angiographically successful PCI CTO without any remaining lesion at least 30% proximal to the stented segment.
4. Possibility to perform physiologic measurements and OCT of sufficient quality.
5. Patients willing and capable to provide written informed consent.

Exclusion Criteria:

1) Contra-indication for adenosine.

Contacts and Locations

Contacts

Contact: Leonie Prins, MSc; 0031 38 426 2999; l.prins@diagram-zwolle.nl

Locations

Netherlands

Isala; Recruiting

Zwolle, Netherlands, 8025 AB

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

Contact: Miguel Lemmert, PhD 0031 38 424 2374 m.e.lemmert@isala.nl

Principal Investigator: Maarten Van Leeuwen, PhD

Sub-Investigator: Miguel Lemmert, PhD

Sub-Investigator: Tom Meijers, MD MSc

Sponsors and Collaborators

Maatschap Cardiologie Zwolle

Abbott

Diagram B.V.

Investigators

• Principal Investigator: Maarten Van Leeuwen, PhD; Isala Zwolle

More Information

• Responsible Party: Maatschap Cardiologie Zwolle
• ClinicalTrials.gov Identifier: NCT04780971
• Other Study ID Numbers: 9346
• First Posted: March 4, 2021
• Last Update Posted: September 5, 2021
• Last Verified: August 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maatschap Cardiologie Zwolle:

percutaneous coronary intervention; chronic total occlusion; intra-coronary physiology; optical coherence tomography