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Recruiting NCT05244629

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

No phase Interventional Mesenteric Ischemia Bowel; Ischemic Superior Mesenteric Atherosclerosis Mesenteric Artery Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BMS vs. CS.
Who it may be relevant to
Registry conditions: Mesenteric Ischemia, Bowel; Ischemic, Superior Mesenteric Atherosclerosis, Mesenteric Artery Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device BMS vs. CS
    Patients will be randomized to treatment with either BeSmooth (BMS, Bentley Innomed GmBh) or BeGraft (CS, Bentley Innomed Gmbh)

Primary outcome measures

  • Number of patients with open stents after 12 months [Time frame: 12 months]
Secondary outcome measures (2)
  • Survival [Time frame: 5 years]
  • Quality of life accoring to SF 36 variables [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Department of Vascular Surgery, Heart Center, Copenhagen University Hospital - Rigshospita — København Ø

Publications

  • Brandtzag AA, Eiberg JP, Lonn L, Taudorf M, Resch TA. Copenhagen Mesenteric stent study (COMESS)-a randomized trial of stent versus covered stent treatment for chronic mesenteric ischemia. Trials. 2024 Jun 28;25(1):426. doi: 10.1186/s13063-024-08285-5. PMID 38943169

Identifiers

NCT: NCT05244629 · 88754

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗