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

Summary

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.

Conditions

• 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

Interventions

DEVICE

BMS vs. CS

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

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Timothy A Resch, MD, PhD · Deptarment of Vascular Surgery, Rigshospitalet

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-30

Primary Completion

2024-08-31

Completion

2029-08-31

Countries

• Denmark

Study Locations