NCT07059520 Translesional PRESSURE Measurements to Assess Clinical Relevance of a Mesenteric Artery Stenosis (PRESSURE-study)
| NCT ID | NCT07059520 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Chronic Mesenteric Ischemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 125 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 125 participants in total. It began in 2025-04-01 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07059520 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Mesenteric Ischemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07059520 currently recruiting?
Yes, NCT07059520 is actively recruiting participants. Contact the research team at e.bocharewicz@erasmusmc.nl for enrollment information.
Where is the NCT07059520 trial being conducted?
This trial is being conducted at Enschede, Netherlands, Rotterdam, Netherlands, Rotterdam, Netherlands.
Who is sponsoring the NCT07059520 clinical trial?
NCT07059520 is sponsored by Erasmus Medical Center. The trial plans to enroll 125 participants.