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Pressure

Translesional pressure measurements to assess clinical relevance of a mesenteric artery stenosis - Pressure

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57447
Enrollment
125
Registered
2024-07-17
Start date
2025-04-04
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic mesenteric ischemia Intra-arterial pressure measurements Mesenteric artery stenting Narrowed arteries of the digestive system

Interventions

Dräger Infinity C300 external pressure measurement system (CE marked, MDD93/42, CE mark article code: OP90127).&nbsp

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. All patients with CMI undergoing an endovascular procedure of the mesenteric arteries2. Age =18 years of age 3. Patients who gave informed consent

Exclusion criteria

Exclusion criteria: 1. Patients presenting with acute mesenteric ischemia2. Common origin of the SMA and CA (normal variant)3. Contraindication of nitroglycerin4. Patients unable to give informed consent5. Pregnancy6. Other criteria the physician considers not compatible with this study 

Design outcomes

Primary

MeasureTime frame
To assess the predictive performance of the Pd/Pa ratio before and after administration of a vasodilator to predict the clinical success ofmesenteric artery stenting.

Secondary

MeasureTime frame
- To assess the improvement in quality of life after a successful endovascular mesenteric artery revascularization procedure- To compare the improvement in quality of life between patients with pressure measurements indicating clinical success of revascularization and patients with pressure measurements indicating no clinical success of revascularization- To assess the cost-effectiveness of future implementation of intra-arterial pressure measurements prior to a mesenteric artery revascularization- To assess the predictive performance of pressure measurements to predict clinical success of mesenteric artery stenting in patients with stenosis of a single mesenteric artery.- To assess the predictive performance of pressure measurements to predict clinical success of mesenteric artery stenting in patients with stenosis of =2 mesenteric arteries.- To assess the predictive performance of pressure measurements to predict clinical success of mesenteric artery stenting in patients with a stenosis of 50-70%.- To assess the predictive performance of pressure measurements to predict clinical success of mesenteric artery stenting in patients with an in stent stenosis.- To determine the correlation of pressure measurements with the severity of stenosis.- To determine the duration of pressure measurements.- Register complications within 30 days after mesenteric artery pressure measurements.- To compute the pressure drop using computational models- To compare the computed to the measured pressure drop

Countries

Netherlands

Contacts

Public ContactK. Pieterman

Erasmus MC, Universitair Medisch Centrum Rotterdam

imaging.trialbureau@erasmusmc.nl0107033612

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026