Copenhagen Mesenteric Stent Study - A Randomized Trial of Stent Versus Covered Stent Treatment for Chronic Mesenteric Ischemia

Study Overview
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Brief Summary
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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.

Official Title
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Copenhagen Mesenteric Stent Study - A Randomized Trial of Stent Versus Covered Stent Treatment for Chronic Mesenteric Ischemia

Conditions
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Mesenteric Ischemia, Bowel; Ischemic, Superior Mesenteric Atherosclerosis, Mesenteric Artery Stenosis, Stent Restenosis, Stent Occlusion, Stent Thrombosis, Stent-Graft Stenosis, Stent-Graft Thrombosis, Stent-Graft Restenosis

Intervention / Treatment
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* Device: BMS vs. CS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with symptomatic CMI of atherosclerotic or atherothrombotic etiology Intended endovascular treatment Symptoms consistent with CMI (pain, weight loss, diarrhea) Significant ostial stenosis (>50%) of the superior mesenteric artery on CTA Significant stenosis on angiography (>50% or >15mmHg pressure gradient) Patients > 18 years Exclusion Criteria: No informed consent Non atherosclerotic cause of MI Acute mesenteric ischemia (AMI) Signs of acute bowel ischemia, peritonitis, laparotomy, sepsis Previous stent treatment in the superior mesenteric artery(ies) Target artery lesions >4cm in length Unable to cross lesion with guidewire Non-significant stenosis angiographically Pregnancy Allergies to contrast media or stent materials

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bare Metal Stent<br> | Device: BMS vs. CS<br>* Patients will be randomized to treatment with either BeSmooth (BMS, Bentley Innomed GmBh) or BeGraft (CS, Bentley Innomed Gmbh)<br>|
| Active Comparator: Covered Stent<br> | Device: BMS vs. CS<br>* Patients will be randomized to treatment with either BeSmooth (BMS, Bentley Innomed GmBh) or BeGraft (CS, Bentley Innomed Gmbh)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with open stents after 12 months | No evidence of occlusion, thrombosis or in-stent restenosis more than 30 percent | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | reintervention free and overall survival | 5 years | 
| Quality of life accoring to SF 36 variables | SF 36 | 5 years |