Evaluation of Covered Stents Versus Bare Metal Stents for Endovascular Treatment of Chronic Ischemia Mesenteric Disease.
- Conditions
- Chronic Mesenteric IschemiaStent Stenosis
- Interventions
- Procedure: endovascular angioplasty using covered stentsProcedure: endovascular angioplasty using bare metal stentsDevice: Duplex-scanDevice: computerized tomography scan (CT-scan)Device: digital angiographyOther: Short Form-36 (SF-36) questionnaire
- Registration Number
- NCT03586739
- Lead Sponsor
- Hospices Civils de Lyon
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 179
- 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.
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description "Covered stents" strategy Duplex-scan - "Covered stents" strategy endovascular angioplasty using covered stents - "Bare metal stents" strategy computerized tomography scan (CT-scan) - "Covered stents" strategy computerized tomography scan (CT-scan) - "Bare metal stents" strategy endovascular angioplasty using bare metal stents - "Bare metal stents" strategy Duplex-scan - "Bare metal stents" strategy Short Form-36 (SF-36) questionnaire - "Covered stents" strategy digital angiography - "Covered stents" strategy Short Form-36 (SF-36) questionnaire - "Bare metal stents" strategy digital angiography -
- Primary Outcome Measures
Name Time Method Freedom from restenosis, 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.
- Secondary Outcome Measures
Name Time Method Occurrence of endovascular procedure complications up to discharge from hospital Quality of life score 12 months after the primary endovascular treatment quality of life will be compared between the two groups and assessed using the SF-36 questionnaire
Freedom of reintervention (endovascular or surgical) 24 months after the primary endovascular treatment Number of patients with maintained primary, primary assisted and secondary patencies 18 months after the primary endovascular treatment Freedom of symptoms recurrence 24 months after the primary endovascular treatment Clinical recurrence, defined as the symptomatic recurrence of chronic, subacute or acute mesenteric ischemia
Occurrence of major morbidity 24 months after the primary endovascular treatment Occurrence of major morbidity and description of the events
Target lesion revascularisation (TLR) 24 months after the primary endovascular treatment Repeat revascularisation for a lesion anywhere within the primary stent or the 5-mm borders proximal or distal to the stent
Freedom from restenosis 12 months after the primary endovascular treatment 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.
Trial Locations
- Locations (20)
Département de Chirurgie Vasculaire, CHRU Hôpital Cardiologique de Lille
🇫🇷Lille, France
Département de Chirurgie Vasculaire? CHU J. Minjoz Besançon
🇫🇷Besançon, France
Service de Chirurgie Vasculaire, CHU de Brest, Hôpital de La Cavale Blanche
🇫🇷Brest, France
Département de Chirurgie Cardio-Vasculaire, CHU Le Bocage Dijon Bourgogne
🇫🇷Dijon, France
Département de Chirurgie Vasculaire, CHU Toulouse - Hôpital Rangueil
🇫🇷Toulouse, France
Département de Chirurgie Vasculaire, Centre Hospitalier Saint Philibert, Lomme
🇫🇷Lomme, France
Département de Chirurgie Vasculaire, APHP Hôpital Ambroise Paré
🇫🇷Boulogne-Billancourt, France
Département de Chirurgie Vasculaire, CHU Nice - Hôpital Pasteur
🇫🇷Nice, France
Département de Chirurgie Vasculaire, CHU Pontchailloux Rennes
🇫🇷Rennes, France
Département de Chirurgie Vasculaire, CHU de Rouen
🇫🇷Rouen, France
Département de Chirurgie Vasculaire, CHU Amiens Picardie - Site Sud
🇫🇷Salouël, France
Département de Chirurgie Vasculaire? CHU Nancy - Hôpital Brabois
🇫🇷Vandœuvre-lès-Nancy, France
Département de Chirurgie Vasculaire, CHU d'Angers
🇫🇷Angers, France
Département de Chirurgie Vasculaire, CHU Clermont-Ferrand - Hôpital G. Montpied
🇫🇷Clermont-Ferrand, France
Département de Chirurgie Vasculaire, CHU Marseille - Hôpital la Timone
🇫🇷Marseille, France
Hopital Lyon Sud
🇫🇷Pierre-Bénite, France
Service de Chirurgie Vasculaire, CHU de Strasbourg, Nouvel Hôpital Civil
🇫🇷Strasbourg, France
APHP Hôpital Bichat - Claude Bernard
🇫🇷Paris, France
Département de Chirurgie Vasculaire, CHU Poitiers - Hôpital Jean Bernard
🇫🇷Poitiers, France
Département de Chirurgie Vasculaire, APHP Hôpital de la Pitié-Salpêtrière
🇫🇷Paris, France