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PRESSURE
Sponsor study identifier
observational
125
1 country
3
Study Start
April 1, 2025
Actual (reported)Primary Completion
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2025
Actual (reported)July 1, 2025
Actual (reported)July 10, 2025
Actual (reported)July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Patients with a consensus diagnosis of chronic mesenteric ischemia who are scheduled for endovascular treatment
All patients undergoing an interventional or diagnostic endovascular procedure of the mesenteric arteries are eligible for inclusion.
Medisch Spectrum Twente
Enschede, Overijssel, 7512KZ, Netherlands
Erasmus University Medical Centre Rotterdam
Rotterdam, South Holland, 3015GD, Netherlands
van Petersen AS, Kolkman JJ, Meerwaldt R, Huisman AB, van der Palen J, Zeebregts CJ, Geelkerken RH. Mesenteric stenosis, collaterals, and compensatory blood flow. J Vasc Surg. 2014 Jul;60(1):111-9, 119.e1-2. doi: 10.1016/j.jvs.2014.01.063. Epub 2014 Mar 18.
Sadiq I, Chamakura S, Siddiqi S, Margey R, Azemi T. Use of fractional flow reserve in the assessment of chronic mesenteric ischemia. Vasc Med. 2014 Jun;19(3):182-188. doi: 10.1177/1358863X14529617. Epub 2014 May 30.
First Submitted
July 1, 2025
First Posted
July 10, 2025
Study Start
April 1, 2025
Actual (reported)Primary Completion
July 1, 2027
EstimatedContact the study team to confirm eligibility.
Franciscus
Rotterdam, South Holland, 3045PM, Netherlands
Takiguchi T, Nakajima M, Ohbe H, Sasabuchi Y, Matsui H, Fushimi K, Kim S, Yokota H, Yasunaga H. Vasodilator Therapy and Mortality in Nonocclusive Mesenteric Ischemia: A Nationwide Observational Study. Crit Care Med. 2020 May;48(5):e356-e361. doi: 10.1097/CCM.0000000000004255.
Twiner MJ, Hennessy J, Wein R, Levy PD. Nitroglycerin Use in the Emergency Department: Current Perspectives. Open Access Emerg Med. 2022 Jul 9;14:327-333. doi: 10.2147/OAEM.S340513. eCollection 2022.
Boyer N, Beyer A, Gupta V, Dehghani H, Hindnavis V, Shunk K, Zimmet J, Yeghiazarians Y, Ports T, Boyle A. The effects of intra-arterial vasodilators on radial artery size and spasm: implications for contemporary use of trans-radial access for coronary angiography and percutaneous coronary intervention. Cardiovasc Revasc Med. 2013 Nov-Dec;14(6):321-4. doi: 10.1016/j.carrev.2013.08.009. Epub 2013 Oct 2.
Bertrand OF, Rao SV, Pancholy S, Jolly SS, Rodes-Cabau J, Larose E, Costerousse O, Hamon M, Mann T. Transradial approach for coronary angiography and interventions: results of the first international transradial practice survey. JACC Cardiovasc Interv. 2010 Oct;3(10):1022-31. doi: 10.1016/j.jcin.2010.07.013.
Pillai AK, Kalva SP, Hsu SL, Walker TG, Silberzweig JE, Annamalai G, Baerlocher MO, Mitchell JW, Midia M, Nikolic B, Dariushnia SR; Society of Interventional Radiology Standards of Practice Committee. Quality Improvement Guidelines for Mesenteric Angioplasty and Stent Placement for the Treatment of Chronic Mesenteric Ischemia. J Vasc Interv Radiol. 2018 May;29(5):642-647. doi: 10.1016/j.jvir.2017.11.024. Epub 2018 Mar 21. No abstract available.
Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.
Garcia LA, Carrozza JP Jr. Physiologic evaluation of translesion pressure gradients in peripheral arteries: comparison of pressure wire and catheter-derived measurements. J Interv Cardiol. 2007 Feb;20(1):63-5. doi: 10.1111/j.1540-8183.2007.00213.x.
Imbesi SG, Kerber CW. Pressure Measurements across Vascular Stenoses. Practice and Pitfalls. Interv Neuroradiol. 1999 Jun 30;5(2):139-44. doi: 10.1177/159101999900500205. Epub 2001 May 15.
Moneta GL, Yeager RA, Dalman R, Antonovic R, Hall LD, Porter JM. Duplex ultrasound criteria for diagnosis of splanchnic artery stenosis or occlusion. J Vasc Surg. 1991 Oct;14(4):511-8; discussion 518-20.
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
Bjorck M, Koelemay M, Acosta S, Bastos Goncalves F, Kolbel T, Kolkman JJ, Lees T, Lefevre JH, Menyhei G, Oderich G, Esvs Guidelines Committee, Kolh P, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Sanddal Lindholt J, Vega de Ceniga M, Vermassen F, Verzini F, Document Reviewers, Geelkerken B, Gloviczki P, Huber T, Naylor R. Editor's Choice - Management of the Diseases of Mesenteric Arteries and Veins: Clinical Practice Guidelines of the European Society of Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2017 Apr;53(4):460-510. doi: 10.1016/j.ejvs.2017.01.010. No abstract available.
van Dijk LJD, Harki J, van Noord D, Verhagen HJM, Kolkman JJ, Geelkerken RH, Bruno MJ, Moelker A; Dutch Mesenteric Ischemia Study group (DMIS). Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI): study protocol for a randomized controlled trial. Trials. 2019 Aug 20;20(1):519. doi: 10.1186/s13063-019-3609-8.
Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013 Sep;22(7):1717-27. doi: 10.1007/s11136-012-0322-4. Epub 2012 Nov 25.
Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ. 2002 Mar;21(2):271-92. doi: 10.1016/s0167-6296(01)00130-8.
Mensink PB, Moons LM, Kuipers EJ. Chronic gastrointestinal ischaemia: shifting paradigms. Gut. 2011 May;60(5):722-37. doi: 10.1136/gut.2009.199695. Epub 2010 Nov 29.
van Dijk LJD, Terlouw LG, van Noord D, Bijdevaate DC, Bruno MJ, Moelker A. Endovascular Pressure Measurements to Assess the Functional Severity of Mesenteric Arterial Stenoses. J Vasc Interv Radiol. 2020 Mar;31(3):430-437. doi: 10.1016/j.jvir.2019.10.019. Epub 2020 Jan 29.
van Dijk LJ, van Noord D, de Vries AC, Kolkman JJ, Geelkerken RH, Verhagen HJ, Moelker A, Bruno MJ. Clinical management of chronic mesenteric ischemia. United European Gastroenterol J. 2019 Mar;7(2):179-188. doi: 10.1177/2050640618817698. Epub 2018 Dec 4.
van Petersen AS, Kolkman JJ, Gerrits DG, van der Palen J, Zeebregts CJ, Geelkerken RH; Dutch Mesenteric Ischemia Study Group. Clinical significance of mesenteric arterial collateral circulation in patients with celiac artery compression syndrome. J Vasc Surg. 2017 May;65(5):1366-1374. doi: 10.1016/j.jvs.2016.11.052. Epub 2017 Mar 2.
van den Heuvel TRA, Jeuring SFG, Zeegers MP, van Dongen DHE, Wolters A, Masclee AAM, Hameeteman WH, Romberg-Camps MJL, Oostenbrug LE, Pierik MJ, Jonkers DM. A 20-Year Temporal Change Analysis in Incidence, Presenting Phenotype and Mortality, in the Dutch IBDSL Cohort-Can Diagnostic Factors Explain the Increase in IBD Incidence? J Crohns Colitis. 2017 Oct 1;11(10):1169-1179. doi: 10.1093/ecco-jcc/jjx055.
Howard DP, Banerjee A, Fairhead JF, Handa A, Silver LE, Rothwell PM; Oxford Vascular Study. Age-specific incidence, risk factors and outcome of acute abdominal aortic aneurysms in a defined population. Br J Surg. 2015 Jul;102(8):907-15. doi: 10.1002/bjs.9838. Epub 2015 May 7.
Terlouw LG, Verbeten M, van Noord D, Brusse-Keizer M, Beumer RR, Geelkerken RH, Bruno MJ, Kolkman JJ; Dutch Mesenteric Ischemia Study Group. The Incidence of Chronic Mesenteric Ischemia in the Well-Defined Region of a Dutch Mesenteric Ischemia Expert Center. Clin Transl Gastroenterol. 2020 Aug;11(8):e00200. doi: 10.14309/ctg.0000000000000200.
Blauw JTM, Pastoors HAM, Brusse-Keizer M, Beuk RJ, Kolkman JJ, Geelkerken RH, For The Dutch Mesenteric Ischemia Study Group. The Impact of Revascularisation on Quality of Life in Chronic Mesenteric Ischemia. Can J Gastroenterol Hepatol. 2019 Nov 12;2019:7346013. doi: 10.1155/2019/7346013. eCollection 2019.
Alahdab F, Arwani R, Pasha AK, Razouki ZA, Prokop LJ, Huber TS, Murad MH. A systematic review and meta-analysis of endovascular versus open surgical revascularization for chronic mesenteric ischemia. J Vasc Surg. 2018 May;67(5):1598-1605. doi: 10.1016/j.jvs.2017.12.046. Epub 2018 Mar 20.
Terlouw LG, Moelker A, Abrahamsen J, Acosta S, Bakker OJ, Baumgartner I, Boyer L, Corcos O, van Dijk LJ, Duran M, Geelkerken RH, Illuminati G, Jackson RW, Karkkainen JM, Kolkman JJ, Lonn L, Mazzei MA, Nuzzo A, Pecoraro F, Raupach J, Verhagen HJ, Zech CJ, van Noord D, Bruno MJ. European guidelines on chronic mesenteric ischaemia - joint United European Gastroenterology, European Association for Gastroenterology, Endoscopy and Nutrition, European Society of Gastrointestinal and Abdominal Radiology, Netherlands Association of Hepatogastroenterologists, Hellenic Society of Gastroenterology, Cardiovascular and Interventional Radiological Society of Europe, and Dutch Mesenteric Ischemia Study group clinical guidelines on the diagnosis and treatment of patients with chronic mesenteric ischaemia. United European Gastroenterol J. 2020 May;8(4):371-395. doi: 10.1177/2050640620916681. Epub 2020 Apr 16.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 31, 2025
Record last verified: 2025-07
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