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

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.

NCT Number	NCT07059520
Lead Sponsor	Erasmus Medical Center
Conditions	Chronic Mesenteric Ischemia, Ischemia, Mesenteric
Enrollment	125 participants
Start Date	2025-04-01
Primary Completion	2027-07-01 (estimated)
Study Completion	2028-01-01 (estimated)
Updated on ClinicalTrials.gov	2025-07-31