Condition: Mesenteric Ischemia · Bowel; Ischemic · Superior Mesenteric Atherosclerosis · Sponsor: Rigshospitalet, Denmark
Chronic mesenteric ischemia (CMI) is often caused by narrowings in the arteries providing blood to the intestines. Endovascular stent placement is considered the preferred treatment for this condition. Guidelines increasingly support the use of so called covered stents (CS) in stead of bare stents (BMS) for this use but the level of evidence for this is limited. Using CS incur additional costs for healthcare short-term but may prevent recurrence of narrowing and symptoms postoperatively benefitting patients and healthcare. Study Objective: To evaluate the outcomes after stenting of mesenteric arteries using BMS or CS. Study Outcome: Primary stent patency 1 year after placement The trial will also evaluate complications, how often stents need to be reoperated, Quality of Life (QoL) and reasons for subjects death Method: This is a so called prospective, randomized controlled trial comparing CS vs. BMS. This means that one patients have agrred to treatment they will be randomly selected for treatment with either CS or BMS . The stent metal structure is identical in the two implants and the only difference is the graft covering, making this study unique. The study will also collect blood samples for a biobank that will be used to study markers of disease and how these effect treatment outcomes. All patients referred to the Department of Vascular Surgery due to CMI are considered for inclusion if they havechronic symptoms consistent with CMI, significant stenosis or occlu…
This description comes directly from the study's public registry record.
Timothy A Resch, MD, PhD · +45 35 45 79 31 · timothy.andrew.resch@regionh.dk
Jonas Eiberg, MD, PhD · +45 35 45 24 08 · jonas.peter.eiberg@regionh.dk
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| Department of Vascular Surgery, Heart Center, Copenhagen University Hospital - Rigshospitalet | København Ø, Denmark | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05244629