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

NCT07059520 | Recruiting

• 1 other identifier: MEC-2024-0491 / 12330
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Mesenteric Ischemia; Ischemia, Mesenteric

Keywords

chronic mesenteric ischemia; Pd/Pa ratio; FFR; Collateral circulation

Outcome Measures

Primary Outcomes (1)

• Pd/Pa ratio after administration of a vasodilator and its association with clinical success of mesenteric artery stenting

  Pd/Pa ratio after administration of a vasodilator and its association with clinical success of mesenteric artery stenting

  From enrollment to 3 months after treatment

Study Arms (1)

Patients with a consensus diagnosis of chronic mesenteric ischemia

Patients with a consensus diagnosis of chronic mesenteric ischemia who are scheduled for endovascular treatment

Eligibility Criteria

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

Study Population

All patients undergoing an interventional or diagnostic endovascular procedure of the mesenteric arteries are eligible for inclusion.

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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (3)

Medisch Spectrum Twente

Enschede, Overijssel, 7512KZ, Netherlands

NOT YET RECRUITING

Erasmus University Medical Centre Rotterdam

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

Franciscus

Rotterdam, South Holland, 3045PM, Netherlands

RECRUITING

Related Publications (26)

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MeSH Terms

Conditions

Mesenteric Ischemia

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Peritoneal Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Eva Karina Bocharewicz, PhD Candidate

CONTACT

+31652216196; e.bocharewicz@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiologist, MD, PhD

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

NL (3)