Clinical trial NCT03586739: Evaluation of Covered Stents Versus Bare Metal Stents for Endovascular Treatment of Chronic Ischemia Mesenteric Disease.
Official title: Evaluation of Covered Stents Versus Bare Metal Stents for Endovascular Treatment of Chronic Atherosclerotic Mesenteric Arterial Disease:a Randomised Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Mesenteric Ischemia
Stent Stenosis
Keywords: Mesenteric Ischemia Chronic
Atherosclerosis
Restenosis
Primary endovascular treatment
Covered stents
Bare metal stents
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Freedom from restenosis,
timeFrame: 24 months after the primary endovascular treatment
Secondary outcomes:
measure: Occurrence of endovascular procedure complications
timeFrame: up to discharge from hospital
measure: Number of patients with maintained primary, primary assisted and secondary patencies
timeFrame: 24 months after the primary endovascular treatment
measure: Number of patients with maintained primary, primary assisted and secondary patencies
timeFrame: 6 months after the primary endovascular treatment
measure: Number of patients with maintained primary, primary assisted and secondary patencies
timeFrame: 12 months after the primary endovascular treatment
measure: Number of patients with maintained primary, primary assisted and secondary patencies
timeFrame: 18 months after the primary endovascular treatment
measure: Target lesion revascularisation (TLR)
timeFrame: 24 months after the primary endovascular treatment
measure: Freedom of symptoms recurrence
timeFrame: 24 months after the primary endovascular treatment
measure: Freedom of reintervention (endovascular or surgical)
timeFrame: 24 months after the primary endovascular treatment
measure: Occurrence of major morbidity
timeFrame: 24 months after the primary endovascular treatment
measure: Quality of life score
timeFrame: 24 months after the primary endovascular treatment
measure: Quality of life score
timeFrame: at inclusion
measure: Quality of life score
timeFrame: 6 months after the primary endovascular treatment
measure: Quality of life score
timeFrame: 12 months after the primary endovascular treatment
measure: Freedom from restenosis
timeFrame: 12 months after the primary endovascular treatment
Other outcomes:
Locations:
city: Angers
country: France
facility: Département de Chirurgie Vasculaire, CHU d'Angers
city: Besançon
country: France
facility: Département de Chirurgie Vasculaire? CHU J. Minjoz Besançon
city: Boulogne-Billancourt
country: France
facility: Département de Chirurgie Vasculaire, APHP Hôpital Ambroise Paré
city: Brest
country: France
facility: Service de Chirurgie Vasculaire, CHU de Brest, Hôpital de La Cavale Blanche
city: Clermont-Ferrand
country: France
facility: Département de Chirurgie Vasculaire, CHU Clermont-Ferrand - Hôpital G. Montpied
city: Dijon
country: France
facility: Département de Chirurgie Cardio-Vasculaire, CHU Le Bocage Dijon Bourgogne
city: Lille
country: France
facility: Département de Chirurgie Vasculaire, CHRU Hôpital Cardiologique de Lille
city: Lomme
country: France
facility: Département de Chirurgie Vasculaire, Centre Hospitalier Saint Philibert, Lomme
city: Marseille
country: France
facility: Département de Chirurgie Vasculaire, CHU Marseille - Hôpital la Timone
city: Nice
country: France
facility: Département de Chirurgie Vasculaire, CHU Nice - Hôpital Pasteur
city: Paris
country: France
facility: Département de Chirurgie Vasculaire, APHP Hôpital de la Pitié-Salpêtrière
city: Paris
country: France
facility: APHP Hôpital Bichat - Claude Bernard
city: Pierre-Bénite
country: France
facility: Hopital Lyon Sud
city: Poitiers
country: France
facility: Département de Chirurgie Vasculaire, CHU Poitiers - Hôpital Jean Bernard
city: Rennes
country: France
facility: Département de Chirurgie Vasculaire, CHU Pontchailloux Rennes
city: Rouen
country: France
facility: Département de Chirurgie Vasculaire, CHU de Rouen
city: Salouël
country: France
facility: Département de Chirurgie Vasculaire, CHU Amiens Picardie - Site Sud
city: Strasbourg
country: France
facility: Service de Chirurgie Vasculaire, CHU de Strasbourg, Nouvel Hôpital Civil
city: Toulouse
country: France
facility: Département de Chirurgie Vasculaire, CHU Toulouse - Hôpital Rangueil
city: Vandœuvre-lès-Nancy
country: France
facility: Département de Chirurgie Vasculaire? CHU Nancy - Hôpital Brabois
Study officials:
References: