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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-16

Study Completion Date

2024-08-28

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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Chronic Total Occlusion Percutaneous Coronary Intervention Quantitative coronary analysis Absolute flow measurement Optical Coherence Tomography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CTO patients undergoing FFR collateral, Absolute flow and OCT measurements

FFR collateral will be measured by measuring the wedge pressure distal from the occlusion, and after stent implantation by creating a balloon-over-the-wire occlusion.

MLD will be measured with quantitative coronary analysis (QCA)

Absolute flow will be measured by using a rayflow catheter with a pressure wire, and by using the Coroventis system.

OCT will be performed during follow-up, using an OCT catheter and perform a pullback through the entire stent trajectory.

No interventions assigned to this group

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Radboudumc

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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111578

Identifier Type: -

Identifier Source: org_study_id