Actively Recruiting

Age: 18Years +
All Genders
NCT07059520

Translesional PRESSURE Measurements to Assess Clinical Relevance of a Mesenteric Artery Stenosis (PRESSURE-study)

Led by Erasmus Medical Center · Updated on 2025-07-31

125

Participants Needed

3

Research Sites

143 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Chronic mesenteric ischemia (CMI) is an incapacitating disease with a vast impact on quality of life due to severe abdominal pain after a meal, resulting in fear of eating and subsequent weight loss. CMI is most frequently caused by an atherosclerotic mesenteric artery stenosis, which is a frequent finding in the general population (6-29%). CMI is less prevalent due to an extensive collateral circulation protecting the gut against ischemia. Hence, imaging alone cannot be relied upon, making the diagnosis of CMI challenging. Treatment decisions for atherosclerotic CMI are currently based on history, stenosis severity on imaging, and signs of mesenteric ischemia during a functional test. Yet, sufficiency of the collateral circulation cannot be assessed, resulting in substantial failure to recover from symptoms after stentplacement (27-31% in single vessel disease), unnecessary complications, and avoidable healthcare expenses. A retrospective cohort study by van Dijk et al. reports that intra-arterial pressure measurements could predict clinical success of mesenteric artery revascularization with an 86% sensitivity and 83% specificity, indicating that mesenteric artery pressure measurements could be a highly desired and promising tool for the assessment of hemodynamic and clinical relevance of a mesenteric artery stenosis. Which is sensible, since pressure gradients will only occur when both a severe mesenteric artery stenosis and an insufficient collateral circulation are present. Another advantages of pressure measurements is the ability to simulate the postprandial physiology, using nitroglycerin, enabling measurements when mesenteric blood flow is maximal. Intra-arterial pressure measurements are currently the most promising tool to guide clinical decision making in patients with suspected CMI and could result in major improvements in quality of life by improving clinical success of mesenteric artery revascularization, decreasing complication risks and decreasing healthcare costs by facilitating allocation of health care resources to those patients actually benefitting from treatment.

CONDITIONS

Official Title

Translesional PRESSURE Measurements to Assess Clinical Relevance of a Mesenteric Artery Stenosis (PRESSURE-study)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with chronic mesenteric ischemia (CMI) scheduled for endovascular mesenteric artery procedure
  • Age 18 years or older
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • Acute mesenteric ischemia
  • Common origin of the superior mesenteric artery (SMA) and celiac artery (CA)
  • Unable to give informed consent
  • Pregnancy
  • Other conditions deemed incompatible by the physician

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Medisch Spectrum Twente

Enschede, Overijssel, Netherlands, 7512KZ

Not Yet Recruiting

2

Erasmus University Medical Centre Rotterdam

Rotterdam, South Holland, Netherlands, 3015GD

Actively Recruiting

3

Franciscus

Rotterdam, South Holland, Netherlands, 3045PM

Actively Recruiting

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Research Team

E

Eva Karina Bocharewicz, PhD Candidate

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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