Use of Physiology to Evaluate Procedural Result After PCI CTO

Complex Coronary Lesion Clinical Trial

— ULTRA-CTO  

Official title:

Use of Physiology to Evaluate Procedural Result After PCI CTO

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04780971
• Other study ID #: 9346
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2021
• Est. completion date: June 2024

Study information

• Verified date: June 2023
• Source: Maatschap Cardiologie Zwolle
• Contact: Maarten van Leeuwen, PhD
• Phone: 0031 38 424 2374
• Email: m.a.h.van.leeuwen[@]isala.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Complex Coronary Lesion
• Percutaneous Coronary Revascularisation

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Isala	Zwolle

Sponsors (3)

Lead Sponsor	Collaborator
Maatschap Cardiologie Zwolle	Abbott, Radboudumc Technology Center; Clinical Studies

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 and 4 weeks
Secondary	Seattle Angina Questionnaire (SAQ) score at 4 weeks	Seattle Angina Questionnaire (SAQ) score at 4 weeks	4 weeks
Secondary	New York Heart Association (NYHA) classification at 4 weeks	New York Heart Association (NYHA) classification (I, II, III or IV) at 4 weeks	4 weeks
Secondary	Canadian Cardiovascular Society (CCS) classification at 4 weeks	Canadian Cardiovascular Society (CCS) classification (I, II, III, IV) at 4 weeks	4 weeks
Secondary	Occurrence of target lesion revascularization (TLR) at 4 weeks	Occurrence of target lesion revascularization (TLR) at 4 weeks	4 weeks
Secondary	Occurrence of stent thrombosis (ST) at 4 weeks	Occurrence of stent thrombosis (ST) at 4 weeks	4 weeks
Secondary	Occurrence of target vessel failure (TVF) at 4 weeks	Occurrence of target vessel failure (TVF) at 4 weeks	4 weeks
Secondary	Occurrence of the composite endpoint of all-cause mortality, myocardial infarction and any coronary revascularization (MACE) at 4 weeks	Occurrence of the composite endpoint of all-cause mortality, myocardial infarction and any coronary revascularization (MACE) at 4 weeks	4 weeks
Secondary	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 PCI CTO until staged procedure at 4 weeks
Secondary	The correlation of post-PCI RFR and -FFR with SSR at 4 weeks.	The correlation of post-PCI RFR and -FFR with SSR at 4 weeks.	During staged procedure (4 weeks after index CTO PCI)
Secondary	The change in resting full-cycle ratio (RFR) over a period of 4 weeks after CTO PCI.	The change in resting full-cycle ratio (RFR) over a period of 4 weeks after CTO PCI.	Index PCI CTO until staged procedure at 4 weeks
Secondary	The change in fractional flow reserve (FFR) over a period of 4 weeks after CTO PCI.	The change in fractional flow reserve (FFR) over a period of 4 weeks after CTO PCI.	Index PCI CTO until staged procedure at 4 weeks
Secondary	The change in pressure-distal / pressure-aorta (Pd/Pa) over a period of 4 weeks after CTO PCI.	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.	Index PCI CTO until staged procedure at 4 weeks
Secondary	The change in coronary flow reserve (CFR) over a period of 4 weeks after CTO PCI.	The change in coronary flow reserve (CFR) over a period of 4 weeks after CTO PCI.	Index PCI CTO until staged procedure at 4 weeks
Secondary	The correlation between positive RFR (=0.89) and positive FFR (=0.80) following angiographically satisfactory CTO PCI.	The correlation between positive RFR (=0.89) and positive FFR (=0.80) following angiographically satisfactory CTO PCI.	During index CTO PCI
Secondary	The incidence and change of microvascular dysfunction as assessed by IMR over a period of 4 weeks after CTO PCI.	The incidence and change of microvascular dysfunction as assessed by IMR over a period of 4 weeks after CTO PCI.	Index PCI CTO until staged procedure at 4 weeks
Secondary	The correlation between post-PCI physiology (OCT, RFR, FFR, CFR, IMR) and suboptimal stent result (SSR) with anginal complaints (SAQ score) at 4 weeks.	The correlation between post-PCI physiology (OCT, RFR, FFR, CFR, IMR) and suboptimal stent result (SSR) with anginal complaints (SAQ score) at 4 weeks.	During staged procedure (4 weeks after index CTO PCI)
Secondary	The impact on physician-decision making based on OCT and physiology findings at 4 weeks.	The impact on physician-decision making based on OCT and physiology findings at 4 weeks.	During staged procedure (4 weeks after index CTO PCI)