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

Recruiting now

Conditions studied: Chronic Mesenteric Ischemia, Ischemia, Mesenteric

In brief

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.

Key facts

Study ID

NCT07059520

Run by

Erasmus Medical Center

People needed

125

Starts

2025-04-01

Expected to finish

2028-01-01

Last updated by the study team

2025-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients with chronic mesenteric ischemia (CMI) and scheduled for endovascular procedure of the mesenteric arteries
• Age ≥18 years of age
• Patients who gave informed consent

You may not qualify if…

• Patients presenting with acute mesenteric ischemia
• Common origin of the SMA and CA (normal variant)
• Patients unable to give informed consent
• Pregnancy
• Other criteria the physician considers not compatible with this study

Where it is running

• Erasmus University Medical Centre Rotterdam — Rotterdam, South Holland, Netherlands (enrolling)
• Franciscus — Rotterdam, South Holland, Netherlands (enrolling)
• Medisch Spectrum Twente — Enschede, Overijssel, Netherlands

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.