Clinical trial NCT04780971: Use of Physiology to Evaluate Procedural Result After PCI CTO
Official title: Use of Physiology to Evaluate Procedural Result After PCI CTO
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Percutaneous Coronary Revascularisation
Complex Coronary Lesion
Keywords: percutaneous coronary intervention
chronic total occlusion
intra-coronary physiology
optical coherence tomography
Lead sponsor: Isala
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2021-03-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: The AUC of post-PCI RFR compared to the AUC of post-PCI FFR with regard to SSR.
timeFrame: Index procedure (or staged procedure if indicated).
Secondary outcomes:
measure: Seattle Angina Questionnaire (SAQ) score at follow-up
timeFrame: 4± 2 weeks
measure: New York Heart Association (NYHA) classification at follow-up
timeFrame: 4± 2 weeks
measure: Canadian Cardiovascular Society (CCS) classification at follow-up
timeFrame: 4± 2 weeks
measure: Occurrence of the composite endpoint of all-cause mortality, myocardial infarction and any coronary revascularization (MACE) at follow-up
timeFrame: 4± 2 weeks
measure: The predictive value of the RFR and FFR gradient across the stented segment with regard to SSR in CTO patients.
timeFrame: Index procedure (or staged procedure if indicated).
measure: The correlation between positive RFR (≤0.89) and positive FFR (≤0.80) with regard to SSR following angiographically satisfactory CTO PCI.
timeFrame: Index procedure (or staged procedure if indicated).
measure: 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
timeFrame: Index procedure (or staged procedure if indicated) until 4± 2 weeks follow-up
measure: The impact on physician-decision making based on OCT and physiology findings
timeFrame: Index procedure (or staged procedure if indicated).
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Zwolle
country: Netherlands
facility: Isala
Study officials:
affiliation: Isala Zwolle
name: Maarten Van Leeuwen, PhD
role: PRINCIPAL_INVESTIGATOR
References: