Copenhagen Mesenteric Stent Study - A Randomized Trial of Stent Versus Covered Stent Treatment for Chronic Mesenteric Ischemia
COMESS
1 other identifier
interventional
98
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2022
CompletedFirst Posted
Study publicly available on registry
February 17, 2022
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2029
ExpectedJune 12, 2023
June 1, 2023
1.2 years
February 8, 2022
June 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Survival
5 years
Quality of life accoring to SF 36 variables
5 years
Study Arms (2)
Bare Metal Stent
ACTIVE COMPARATORCovered Stent
ACTIVE COMPARATORInterventions
Patients will be randomized to treatment with either BeSmooth (BMS, Bentley Innomed GmBh) or BeGraft (CS, Bentley Innomed Gmbh)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- University of Copenhagencollaborator
Study Sites (1)
Department of Vascular Surgery, Heart Center, Copenhagen University Hospital - Rigshospitalet
København Ø, 2100, Denmark
Related Publications (1)
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: 38943169DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy A Resch, MD, PhD
Deptarment of Vascular Surgery, Rigshospitalet
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Vascular Surgery
Study Record Dates
First Submitted
February 8, 2022
First Posted
February 17, 2022
Study Start
June 1, 2023
Primary Completion
August 1, 2024
Study Completion (Estimated)
August 1, 2029
Last Updated
June 12, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share