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

NCT06728384 | Completed

• 1 other identifier: 111578
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Acute FFR collateral change

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

  30 minutes

• Late FFR collateral change

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

  3 months

• Acute MLD change

  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

  30 minutes

• Late MLD change

  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

  3 months

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: December 16, 2021
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)