An interventional study of endovascular angioplasty using covered stents and endovascular angioplasty using bare metal stents in Chronic Mesenteric Ischemia and Stent Stenosis, sponsored by Hospices Civils de Lyon. Completed at 20 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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
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
Primary endovascular angioplasty using one or several covered stents
Primary endovascular angioplasty using one or several bare metal stents
a Duplex-scan will be performed during patient follow up.
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.
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.
The patient will complete a quality-of-life questionnaire (SF-36 form) during their follow up.
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.
Time frame: 24 months after the primary endovascular treatment
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)
Repeat revascularisation for a lesion anywhere within the primary stent or the 5-mm borders proximal or distal to the stent
Time frame: 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
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
Occurrence of major morbidity and description of the events
Time frame: 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
Time frame: 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
Time frame: at inclusion
Quality of life score
quality of life will be compared between the two groups and assessed using the SF-36 questionnaire
Time frame: 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
Time frame: 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.
Time frame: 12 months after the primary endovascular treatment
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospices Civils de Lyon