Remodeling of Distal Coronary Vessel in Chronic Total Occlusions: Prediction Based on Hemodynamic Coronary Parameters

Background Revascularization of a chronic total occlusion (CTO) has gained popularity last decade. After recanalization there is an acute gain in vessel diameter, as well as a late lumen gain distal to the stent as a result of positive remodeling. The evolution of a recanalized CTO-vessel is however diverse. Several studies are performed to measure distal lumen gain and hemodynamic coronary parameters of a recanalized CTO, including the novel measurement Absolute Flow. Although the results seem promising, an association between those parameters and distal vessel lumen gain has never been found. The aim of this study is to understand the remodeling of the distal coronary vessel in relation with hemodynamic coronary parameters, establishing baseline predictive factors, adding new information about coronary physiology.

Objectives:

To establish baseline predictive factors for acute and late lumen growth after successful opening of chronic total occlusions. Secondary objectives are 1) Identifying the relation between change in absolute microvascular resistance and late change distal lumen diameter at the end of the index procedure and at 3 months follow-up, 2) Identifying the relation between late lumen growth and stent malapposition, assessed using Optical Coherence Tomography (OCT) and 3) Identifying the relation between angina-related symptoms, assessed using the Seattle Angina Questionnaire-7 (SAQ-7), and absolute microvascular resistance.

Hypothesis:

Acute and late lumen growth are dependent on preprocedural distal coronary artery perfusion pressure, decrease in microvascular resistance and growth of absolute antegrade flow. Late lumen growth predisposes for late stent malapposition.

Study design:

A single-center, prospective, observational cohort study. The center performing this study will be the Radboudumc.

Study Population:

30 patients scheduled for an elective revascularization procedure of a CTO and Heart-team consensus for the indication of a CTO treatment.

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Key information

Conditions

Chronic Total Occlusion (CTO) Absolute Flow Measurement Fractional Flow Reserve Optical Coherence Tomography (OCT) Percutaneous Coronary Intervention (PCI) Quantitative Coronary Analysis

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboudumc

Nijmegen, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Scheduled elective revascularization procedure of a CTO, defined as a complete obstruction of a coronary artery with TIMI-0 or TIMI-1 flow and occlusion duration of at least 3 months
Heart-team consensus for the indication of a CTO treatment, based on viability and ischemia testing (using TTE or MRI)
Able to give valid, written informed consent

Exclusion criteria

Unsuccessful crossing of the lesion during PCI
Renal insufficiency defined as eGFR < 30 ml/min
Contra-indications to intravenous adenosine
< 18 years of age
Pregnancy

Treatment and study plan

Primary outcomes

Acute FFR collateral change

Time frame: 30 minutes

Changes in collateral function in rest and hyperaemic state, measured before recanalization and after recanalization
Late FFR collateral change

Time frame: 3 months

Changes in collateral function in rest and hyperaemic state, measured after recanalization and at 3 months follow-up
Acute MLD change

Time frame: 30 minutes

Changes in mean lumen diameter of the treated vessel, measured up to 5 mm distal to the occlusion before recanalization and distal to the stent after recanalization
Late MLD change

Time frame: 3 months

Changes in mean lumen diameter of the treated vessel, measured up to 5 mm distal to the stent after recanalization and at 3 months follow-up

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Acronym: CTO-VR

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Dec 11, 2024
Registry last updated: Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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