Mesenteric IschemiaCOMESSNCT05244629
Copenhagen Mesenteric Stent Study - A Randomized Trial of Stent Versus Covered Stent Treatment for Chronic Mesenteric Ischemia
A study testing BMS vs. CS in people with Mesenteric Ischemia and Bowel; Ischemic, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesenteric Ischemia, Bowel; Ischemic, Superior Mesenteric Atherosclerosis
- What is being tested?
- BMS vs. CS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2023to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Unable to cross lesion with guidewire
- Non-significant stenosis angiographically
- Pregnancy
- Allergies to contrast media or stent materials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Vascular Surgery, Heart Center, Copenhagen University Hospital - Rigshospitalet
København Ø, 2100
Sofie Phillipsen, RN, sophie.phillipsen@regionh.dk
Alexandra Brandtzæg, MD, alexandra.annelie.brandtzaeg@regionh.dk
About this study
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:
Read more
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
- Being tested
- BMS vs. CS
- Medical subject headings
- Mesenteric Ischemia, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS vs. CSDevice
Patients will be randomized to treatment with either BeSmooth (BMS, Bentley Innomed GmBh) or BeGraft (CS, Bentley Innomed Gmbh)
| Study group | Role | What they receive |
|---|---|---|
| Bare Metal Stent | Active comparator | Not described Receives: Device: BMS vs. CS |
| Covered Stent | Active comparator | Not described Receives: Device: BMS vs. CS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with open stents after 12 months
No evidence of occlusion, thrombosis or in-stent restenosis more than 30 percent
Measured: 12 months
Secondary outcomes (2)
Survival
reintervention free and overall survival
Measured: 5 years
Quality of life accoring to SF 36 variables
SF 36
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study startJun 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mesenteric IschemiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Timothy Resch, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Timothy A Resch, MD, PhD, Principal investigator, Deptarment of Vascular Surgery, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244629
- Sponsor's protocol ID
- 88754
- Acronym
- COMESS
- Status last verified
- Jun 2023
- First submitted
- 8 Feb 2022
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38943169
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copenhagen Mesenteric Stent Study - A Randomized Trial of Stent Versus Covered Stent Treatment for Chronic Mesenteric Ischemia
- ClinicalTrials.gov ID
- NCT05244629
- Acronym / sponsor ID
- COMESS / 88754
- Conditions
- Mesenteric Ischemia, Bowel; Ischemic, Superior Mesenteric Atherosclerosis, Mesenteric Artery Stenosis, Stent Restenosis, Stent Occlusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jun 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bare Metal Stent | Active comparator | Device: BMS vs. CS |
| Covered Stent | Active comparator | Device: BMS vs. CS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS vs. CSPatients will be randomized to treatment with either BeSmooth (BMS, Bentley Innomed GmBh) or BeGraft (CS, Bentley Innomed Gmbh) | Device | Bare Metal Stent, Covered Stent |
Primary outcome
Number of patients with open stents after 12 months
Time frame: 12 months
No evidence of occlusion, thrombosis or in-stent restenosis more than 30 percent
2 secondary outcomes
Survival
Time frame: 5 years
Quality of life accoring to SF 36 variables
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Derived from this study: PubMed 38943169Brandtzag 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timothy A Resch, MD, PhD principal investigator
Deptarment of Vascular Surgery, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMS vs. CS in people with Mesenteric Ischemia and Bowel; Ischemic, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothy A Resch, MD, PhD (+45 35 45 79 31 ext. 57931, timothy.andrew.resch@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with open stents after 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05244629, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.