Translesional pressure measurements to see whether a mesenteric artery narrowing causes symptoms.
Translesional PRESSURE Measurements to Assess Clinical Relevance of a Mesenteric Artery Stenosis (PRESSURE-study)
This study will test whether measuring the pressure across a narrowed mesenteric artery helps identify which adults with chronic mesenteric ischemia who are scheduled for endovascular treatment will benefit from treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 3 sites (Enschede, Overijssel and 2 other locations) |
| Trial ID | NCT07059520 on ClinicalTrials.gov |
What this trial studies
This is an observational, multicenter study in which pressure measurements (Pd/Pa or similar translesional metrics) are taken across mesenteric artery stenoses during planned endovascular procedures. Investigators will compare these hemodynamic measurements with imaging, clinical history, and functional test findings and will follow patient-reported symptom relief after revascularization. The goal is to determine whether pressure-guided information better predicts symptomatic improvement than imaging alone. The study includes adult patients with chronic mesenteric ischemia undergoing endovascular management at participating Dutch centers.
Who should consider this trial
Good fit: Adults (≥18 years) with chronic mesenteric ischemia who are scheduled for an endovascular procedure of the mesenteric arteries and can give informed consent are the intended participants.
Not a fit: Patients with acute mesenteric ischemia, normal vascular anatomy variants (common origin of SMA and CA), those unable to consent, pregnant people, or those not undergoing endovascular treatment are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could help avoid unnecessary procedures and improve the chance that patients treated for mesenteric artery narrowing actually experience symptom relief.
How similar studies have performed: Pressure-based (Pd/Pa/FFR-like) methods have been successful and widely adopted in coronary disease and have some supportive retrospective data in mesenteric disease, but prospective validation for mesenteric stenoses is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Enschede, Overijssel and 2 other locations
- Medisch Spectrum Twente — Enschede, Overijssel, Netherlands (Not_yet_recruiting)
- Erasmus University Medical Centre Rotterdam — Rotterdam, South Holland, Netherlands (Recruiting)
- Franciscus — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Eva Karina Bocharewicz, PhD Candidate
- Email: e.bocharewicz@erasmusmc.nl
- Phone: +31652216196
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.