Chronic Mesenteric IschemiaESTIMECNCT03586739
Evaluation of Covered Stents Versus Bare Metal Stents for Endovascular Treatment of Chronic Ischemia Mesenteric Disease.
A study testing endovascular angioplasty using covered stents, endovascular angioplasty using bare metal stents and Duplex-scan in people with Chronic Mesenteric Ischemia and Stent Stenosis, run by Hospices Civils de Lyon at 20 sites in France.
Trial summary
Chronic Mesenteric Ischemia (CMI) is defined by one or more arterial digestive lesions, responsible for severe mesenteric symptoms. The clinical presentation of CMI is characterized by postprandial abdominal pain and weight loss, leading to severe malnutrition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Mesenteric Ischemia, Stent Stenosis
- What is being tested?
- endovascular angioplasty using covered stents, endovascular angioplasty using bare metal stents and Duplex-scan
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 20 sitesFrance
- Study dates
- 12 Dec 2018to 26 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 aged 18 years or older;
- Diagnosis of chronic atherosclerotic mesenteric ischemia or atherosclerosis threatening disorders of digestive perfusion, with stenosis or occlusion of the superior mesenteric artery;
- For whom a primary endovascular intervention by percutaneous transluminal angioplasty using stents has been scheduled (anatomical evaluation, arterial evaluation consistent with endovascular treatment);
- For an ostial or post-ostial stenotic arterial lesion to be treated by only one type of stent authorized in the study according to randomization;
- Having signed an informed consent for participation in the study.
Who cannot join
- Acute mesenteric ischemia;
- Previous revascularisation intervention for chronic mesenteric ischemia;
- For some stenotic arterial lesion to be treated more than one type of stent;
- Chronic renal failure (glomerular filtration rate less than 20 mL per minute);
- Low probability of cooperation of the participant (judged by the investigator);
- Medical or surgical history judged by the investigator to be not compatible with this study;
Show all 10Show fewer
- Adult ward or court (under guardianship or trusteeship);
- Pregnant or lactating woman;
- Person under judicial protection;
- Subject participating in another study having an exclusion period still active.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
Département de Chirurgie Vasculaire, CHU d'Angers
Angers, 49100
Département de Chirurgie Vasculaire? CHU J. Minjoz Besançon
Besançon, 25000
Département de Chirurgie Vasculaire, APHP Hôpital Ambroise Paré
Boulogne-Billancourt, 92100
Service de Chirurgie Vasculaire, CHU de Brest, Hôpital de La Cavale Blanche
Brest, 29200
Département de Chirurgie Vasculaire, CHU Clermont-Ferrand - Hôpital G. Montpied
Clermont-Ferrand, 63000
Département de Chirurgie Cardio-Vasculaire, CHU Le Bocage Dijon Bourgogne
Dijon, 21000
Département de Chirurgie Vasculaire, CHRU Hôpital Cardiologique de Lille
Lille, 59037
Département de Chirurgie Vasculaire, Centre Hospitalier Saint Philibert, Lomme
Lomme, 59462
Département de Chirurgie Vasculaire, CHU Marseille - Hôpital la Timone
Marseille, 13385
Département de Chirurgie Vasculaire, CHU Nice - Hôpital Pasteur
Nice, 06001
Département de Chirurgie Vasculaire, APHP Hôpital de la Pitié-Salpêtrière
Paris, 75651
APHP Hôpital Bichat - Claude Bernard
Paris, 75877
Hopital Lyon Sud
Pierre-Bénite, 69495
Département de Chirurgie Vasculaire, CHU Poitiers - Hôpital Jean Bernard
Poitiers, 86021
Département de Chirurgie Vasculaire, CHU Pontchailloux Rennes
Rennes, 35000
Département de Chirurgie Vasculaire, CHU de Rouen
Rouen, 76000
Département de Chirurgie Vasculaire, CHU Amiens Picardie - Site Sud
Salouël, 80480
Service de Chirurgie Vasculaire, CHU de Strasbourg, Nouvel Hôpital Civil
Strasbourg, 67091
Département de Chirurgie Vasculaire, CHU Toulouse - Hôpital Rangueil
Toulouse, 31059
Département de Chirurgie Vasculaire? CHU Nancy - Hôpital Brabois
Vandœuvre-lès-Nancy, 54500
About this study
Official title: Evaluation of Covered Stents Versus Bare Metal Stents for Endovascular Treatment of Chronic Atherosclerotic Mesenteric Arterial Disease:a Randomised Study.
Chronic Mesenteric Ischemia (CMI) is defined by one or more arterial digestive lesions, responsible for severe mesenteric symptoms. The clinical presentation of CMI is characterized by postprandial abdominal pain and weight loss, leading to severe malnutrition. It is a frequent pathology which affects preferentially the elderly patients of female sex (70%) with cardio-vascular comorbidities. Risk factors include smoking, hypertension, and dyslipidemia.
Despite medical and diagnostic advances, the morbidity and mortality of CMI remain very high (>70%). Optimal management of CMI is based on early diagnosis. Symptomatic patients with CMI should be treated without much delay to relief symptoms (present in 43% patients) and prevent acute mesenteric ischemia.
Read more
The three visceral arteries affected by atherosclerotic disease are coeliac trunc, inferior mesenteric artery and Superior Mesenteric Artery (SMA). The SMA is treated the most frequently, because it is the main relevant artery associated with CMI.
Endovascular treatment (angioplasty and stenting) is considered as the first-line treatment for CMI when feasible. It is indicated especially in the case of high grade stenosis or occlusion of the Superior Mesenteric Artery. Two types of stents can be used for this procedure: bare metal stents (BMS) or covered stents (CS).
Even if BMS are standard care there is no consensus on the type of stent to use.
There are very few reported series with large numbers of patients comparing BMS and CS in this indication. However, to our knowledge, no results from a randomized study addressing this issue have ever been published. These are only retrospective with a low level of evidence (IIb). The largest series compared 147 patients with primary intervention for CMI treatment using BMS versus 42 using CS. Treatment with CS showed better results in terms of symptom recurrence (10% vs 32%, p <0.002), restenosis (12% vs 42%, p <0.0002) and re-interventions (10% vs 42%), after at least 1 year of follow-up. Indeed, endovascular treatment using BMS was associated with high incidence of symptoms recurrence despite the satisfying patency rates in both occluded and stenotic vessels.
There are no international guidelines to recommend the use of one or another sort of stent.
The necessity of a randomised study addressing the issue of bare metal versus covered stents deployment seems to be important.
The investigators propose to demonstrate that covered stents presents a better efficacy than bare metal stents, with a multicenter randomized study involving 24 vascular surgical departments of French University Hospitals.
- Conditions
- Chronic Mesenteric Ischemia, Stent Stenosis
- Being tested
- endovascular angioplasty using covered stents, endovascular angioplasty using bare metal stents, Duplex-scan, computerized tomography scan (CT-scan), digital angiography
- Keywords
- Mesenteric Ischemia Chronic, Atherosclerosis, Restenosis, Primary endovascular treatment, Covered stents, Bare metal stents
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovascular angioplasty using covered stentsProcedure or surgery
Primary endovascular angioplasty using one or several covered stents
endovascular angioplasty using bare metal stentsProcedure or surgery
Primary endovascular angioplasty using one or several bare metal stents
Duplex-scanDevice
a Duplex-scan will be performed during patient follow up.
computerized tomography scan (CT-scan)Device
a CT-scan will be performed in the event of symptoms of recurrence or restenosis as confirmatory exam according to clinical practice during patient follow up.
The CT-scan will be mandatory at 12 and 24 months if it has not been planned in the current practice follow-up.
digital angiographyDevice
In case CT-scan cannot be performed (e.g. occurrence of a non-preexisting contra-indication), a digital angiography will be authorised instead to confirm restenosis during patient follow-up.
Short Form-36 (SF-36) questionnaireOther
The patient will complete a quality-of-life questionnaire (SF-36 form) during their follow up.
| Study group | Role | What they receive |
|---|---|---|
| "Covered stents" strategy | Experimental | Not described Receives: Procedure: endovascular angioplasty using covered stents; Device: Duplex-scan; Device: computerized tomography scan (CT-scan); Device: digital angiography; Other: Short Form-36 (SF-36) questionnaire |
| "Bare metal stents" strategy | Active comparator | Not described Receives: Procedure: endovascular angioplasty using bare metal stents; Device: Duplex-scan; Device: computerized tomography scan (CT-scan); Device: digital angiography; Other: Short Form-36 (SF-36) questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from restenosis,
Freedom from restenosis will be defined as ≥50% luminal reduction and/or thrombosis, confirmed by CT-scan.
The crude percentage of restenosis and/or thrombosis at 24 months will be computed for each group. The survival curves for freedom from restenosis and/or thrombosis will be plotted according to the Kaplan-Meier method and overall survival rates will be estimated.
Measured: 24 months after the primary endovascular treatment
Secondary outcomes (14)
Occurrence of endovascular procedure complications
Measured: up to discharge from hospital
Number of patients with maintained primary, primary assisted and secondary patencies
Measured: 24 months after the primary endovascular treatment
Number of patients with maintained primary, primary assisted and secondary patencies
Measured: 6 months after the primary endovascular treatment
Number of patients with maintained primary, primary assisted and secondary patencies
Measured: 12 months after the primary endovascular treatment
Number of patients with maintained primary, primary assisted and secondary patencies
Measured: 18 months after the primary endovascular treatment
Target lesion revascularisation (TLR)
Repeat revascularisation for a lesion anywhere within the primary stent or the 5-mm borders proximal or distal to the stent
Measured: 24 months after the primary endovascular treatment
Freedom of symptoms recurrence
Clinical recurrence, defined as the symptomatic recurrence of chronic, subacute or acute mesenteric ischemia
Measured: 24 months after the primary endovascular treatment
Freedom of reintervention (endovascular or surgical)
Measured: 24 months after the primary endovascular treatment
Occurrence of major morbidity
Occurrence of major morbidity and description of the events
Measured: 24 months after the primary endovascular treatment
Quality of life score
quality of life will be compared between the two groups and assessed using the SF-36 questionnaire
Measured: 24 months after the primary endovascular treatment
Quality of life score
quality of life will be compared between the two groups and assessed using the SF-36 questionnaire
Measured: at inclusion
Quality of life score
quality of life will be compared between the two groups and assessed using the SF-36 questionnaire
Measured: 6 months after the primary endovascular treatment
Quality of life score
quality of life will be compared between the two groups and assessed using the SF-36 questionnaire
Measured: 12 months after the primary endovascular treatment
Freedom from restenosis
The freedom from restenosis will be defined as ≥50% luminal reduction and/or thrombosis, confirmed by CT-scan.
The crude percentage of restenosis and/or thrombosis at 12 months will be computed for each group. The survival curves for freedom from restenosis and/or thrombosis will be plotted according to the Kaplan-Meier method and overall survival rates will be estimated.
Measured: 12 months after the primary endovascular treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start12 Dec 2018
- Primary completion26 Apr 2024
- Study completion26 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Mesenteric IschemiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586739
- Sponsor's protocol ID
- 69HCL18_0040
- Other IDs
- 2018-A01833-52
- Acronym
- ESTIMEC
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2018
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Covered Stents Versus Bare Metal Stents for Endovascular Treatment of Chronic Atherosclerotic Mesenteric Arterial Disease:a Randomised Study.
- ClinicalTrials.gov ID
- NCT03586739
- Acronym / sponsor ID
- ESTIMEC / 69HCL18_0040
- Conditions
- Chronic Mesenteric Ischemia, Stent Stenosis
- Keywords
- Mesenteric Ischemia Chronic, Atherosclerosis, Restenosis, Primary endovascular treatment, Covered stents, Bare metal stents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 16 Jul 2018 (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 defined by one or more arterial digestive lesions, responsible for severe mesenteric symptoms. The clinical presentation of CMI is characterized by postprandial abdominal pain and weight loss, leading to severe malnutrition. It is a frequent pathology which affects preferentially the elderly patients of female sex (70%) with cardio-vascular comorbidities. Risk factors include smoking, hypertension, and dyslipidemia.
Despite medical and diagnostic advances, the morbidity and mortality of CMI remain very high (>70%). Optimal management of CMI is based on early diagnosis. Symptomatic patients with CMI should be treated without much delay to relief symptoms (present in 43% patients) and prevent acute mesenteric ischemia.
The three visceral arteries affected by atherosclerotic disease are coeliac trunc, inferior mesenteric artery and Superior Mesenteric Artery (SMA). The SMA is treated the most frequently, because it is the main relevant artery associated with CMI.
Endovascular treatment (angioplasty and stenting) is considered as the first-line treatment for CMI when feasible. It is indicated especially in the case of high grade stenosis or occlusion of the Superior Mesenteric Artery. Two types of stents can be used for this procedure: bare metal stents (BMS) or covered stents (CS).
Even if BMS are standard care there is no consensus on the type of stent to use.
There are very few reported series with large numbers of patients comparing BMS and CS in this indication. However, to our knowledge, no results from a randomized study addressing this issue have ever been published. These are only retrospective with a low level of evidence (IIb). The largest series compared 147 patients with primary intervention for CMI treatment using BMS versus 42 using CS. Treatment with CS showed better results in terms of symptom recurrence (10% vs 32%, p <0.002), restenosis (12% vs 42%, p <0.0002) and re-interventions (10% vs 42%), after at least 1 year of follow-up. Indeed, endovascular treatment using BMS was associated with high incidence of symptoms recurrence despite the satisfying patency rates in both occluded and stenotic vessels.
There are no international guidelines to recommend the use of one or another sort of stent.
The necessity of a randomised study addressing the issue of bare metal versus covered stents deployment seems to be important.
The investigators propose to demonstrate that covered stents presents a better efficacy than bare metal stents, with a multicenter randomized study involving 24 vascular surgical departments of French University Hospitals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Covered stents" strategy | Experimental | Procedure: endovascular angioplasty using covered stents, Device: Duplex-scan, Device: computerized tomography scan (CT-scan), Device: digital angiography, Other: Short Form-36 (SF-36) questionnaire |
| "Bare metal stents" strategy | Active comparator | Procedure: endovascular angioplasty using bare metal stents, Device: Duplex-scan, Device: computerized tomography scan (CT-scan), Device: digital angiography, Other: Short Form-36 (SF-36) questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 years or older;
- Diagnosis of chronic atherosclerotic mesenteric ischemia or atherosclerosis threatening disorders of digestive perfusion, with stenosis or occlusion of the superior mesenteric artery;
- For whom a primary endovascular intervention by percutaneous transluminal angioplasty using stents has been scheduled (anatomical evaluation, arterial evaluation consistent with endovascular treatment);
- For an ostial or post-ostial stenotic arterial lesion to be treated by only one type of stent authorized in the study according to randomization;
- Having signed an informed consent for participation in the study.
Key exclusion criteria (10 listed)
- Acute mesenteric ischemia;
- Previous revascularisation intervention for chronic mesenteric ischemia;
- For some stenotic arterial lesion to be treated more than one type of stent;
- Chronic renal failure (glomerular filtration rate less than 20 mL per minute);
- Low probability of cooperation of the participant (judged by the investigator);
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 |
|---|---|---|
| endovascular angioplasty using covered stentsPrimary endovascular angioplasty using one or several covered stents | Procedure or surgery | "Covered stents" strategy |
| endovascular angioplasty using bare metal stentsPrimary endovascular angioplasty using one or several bare metal stents | Procedure or surgery | "Bare metal stents" strategy |
| Duplex-scana Duplex-scan will be performed during patient follow up. | Device | "Bare metal stents" strategy, "Covered stents" strategy |
| computerized tomography scan (CT-scan)a CT-scan will be performed in the event of symptoms of recurrence or restenosis as confirmatory exam according to clinical practice during patient follow up. The CT-scan will be mandatory at 12 and 24 months if it has not been planned in the current practice follow-up. | Device | "Bare metal stents" strategy, "Covered stents" strategy |
| digital angiographyIn case CT-scan cannot be performed (e.g. occurrence of a non-preexisting contra-indication), a digital angiography will be authorised instead to confirm restenosis during patient follow-up. | Device | "Bare metal stents" strategy, "Covered stents" strategy |
| Short Form-36 (SF-36) questionnaireThe patient will complete a quality-of-life questionnaire (SF-36 form) during their follow up. | Other | "Bare metal stents" strategy, "Covered stents" strategy |
Primary outcome
Freedom from restenosis,
Time frame: 24 months after the primary endovascular treatment
Freedom from restenosis will be defined as ≥50% luminal reduction and/or thrombosis, confirmed by CT-scan. The crude percentage of restenosis and/or thrombosis at 24 months will be computed for each group. The survival curves for freedom from restenosis and/or thrombosis will be plotted according to the Kaplan-Meier method and overall survival rates will be estimated.
14 secondary outcomes
Occurrence of endovascular procedure complications
Time frame: up to discharge from hospital
Number of patients with maintained primary, primary assisted and secondary patencies
Time frame: 24 months after the primary endovascular treatment
Number of patients with maintained primary, primary assisted and secondary patencies
Time frame: 6 months after the primary endovascular treatment
Number of patients with maintained primary, primary assisted and secondary patencies
Time frame: 12 months after the primary endovascular treatment
Number of patients with maintained primary, primary assisted and secondary patencies
Time frame: 18 months after the primary endovascular treatment
Target lesion revascularisation (TLR)
Time frame: 24 months after the primary endovascular treatment
Freedom of symptoms recurrence
Time frame: 24 months after the primary endovascular treatment
Freedom of reintervention (endovascular or surgical)
Time frame: 24 months after the primary endovascular treatment
Occurrence of major morbidity
Time frame: 24 months after the primary endovascular treatment
Quality of life score
Time frame: 24 months after the primary endovascular treatment
Quality of life score
Time frame: at inclusion
Quality of life score
Time frame: 6 months after the primary endovascular treatment
Quality of life score
Time frame: 12 months after the primary endovascular treatment
Freedom from restenosis
Time frame: 12 months after the primary endovascular treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endovascular angioplasty using covered stents, endovascular angioplasty using bare metal stents and Duplex-scan in people with Chronic Mesenteric Ischemia and Stent Stenosis, run by Hospices Civils de Lyon at 20 sites in France.
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 5 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: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from restenosis, (time frame: 24 months after the primary endovascular treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2024.