An interventional study of BMS vs. CS in Mesenteric Ischemia, Bowel; Ischemic and Superior Mesenteric Atherosclerosis, sponsored by Rigshospitalet, Denmark. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-12.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Treatment
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 occlusion of the superior mesenteric artery and are > 18 years Subjects not able to provide informed consent or who have non atherosclerotic cause of CMI, signs of acute loss of blood flow to the intestines cannot participate. Previous stent treatment in the superior mesenteric artery, pregnancy, allergies to contrast or stent materials are also reasons for not being included in this trial.
Side effects, risks and disadvantages for participants The risk for procedure-related complications is less than 5% and similar in both study groups. Most short-term complications are related to vascular access sites and consist of local bleeding and thrombosis. Other potential complications include impaired renal function due to contrast use, contrast allergy, arterial dissection and death.
40 studies on the registry are indexed under Mesenteric Ischemia; 14 are open to participants now.
This study's planned enrollment of 98 is below the median of 110 across 14 interventional studies indexed under Mesenteric Ischemia.
Browse Mesenteric Ischemia studies →Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: BMS vs. CS
Device: BMS vs. CS
Patients will be randomized to treatment with either BeSmooth (BMS, Bentley Innomed GmBh) or BeGraft (CS, Bentley Innomed Gmbh)
Number of patients with open stents after 12 months
No evidence of occlusion, thrombosis or in-stent restenosis more than 30 percent
Time frame: 12 months
Survival
reintervention free and overall survival
Time frame: 5 years
Quality of life accoring to SF 36 variables
SF 36
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2023; primary completion for Aug 2024, 14 months later.
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