Evaluation of Covered Stents Versus Bare Metal Stents for Endovascular Treatment of Chronic Ischemia Mesenteric Disease.

Stent Stenosis Clinical Trial

— ESTIMEC  

Official title:

Evaluation of Covered Stents Versus Bare Metal Stents for Endovascular Treatment of Chronic Atherosclerotic Mesenteric Arterial Disease:a Randomised Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03586739
• Other study ID #: 69HCL18_0040
• Secondary ID: 2018-A01833-52
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2018
• Est. completion date: June 4, 2024

Study information

• Verified date: May 2023
• Source: Hospices Civils de Lyon
• Contact: Patrick FEUGIER, Pr
• Phone: 04.78.86.12.72
• Email: patrickfeugier[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 179
• Est. completion date: June 4, 2024
• Est. primary completion date: June 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Mesenteric Ischemia
• Ischemia
• Mesenteric Ischemia
• Stent Stenosis

Intervention

Procedure:
• endovascular angioplasty using covered stents
Primary endovascular angioplasty using one or several covered stents
• endovascular angioplasty using bare metal stents
Primary endovascular angioplasty using one or several bare metal stents

Device:
• Duplex-scan
a Duplex-scan will be performed during patient follow up.
• 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.
• digital angiography
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.

Other:
• Short Form-36 (SF-36) questionnaire
The patient will complete a quality-of-life questionnaire (SF-36 form) during their follow up.

Locations

Country	Name	City	State
France	Département de Chirurgie Vasculaire, CHU d'Angers	Angers
France	Département de Chirurgie Vasculaire? CHU J. Minjoz Besançon	Besançon
France	Service de Chirurgie Vasculaire et Générale, CHU de Bordeaux - Hôpital Pellegrin	Bordeaux
France	Département de Chirurgie Vasculaire, APHP Hôpital Ambroise Paré	Boulogne-Billancourt
France	Service de Chirurgie Vasculaire, CHU de Brest, Hôpital de La Cavale Blanche	Brest
France	Département de Chirurgie Vasculaire, CHU Côte de Nacre Caen	Caen
France	Département de Chirurgie Vasculaire, CHU Clermont-Ferrand - Hôpital G. Montpied	Clermont-Ferrand
France	Département de Chirurgie Vasculaire, APHP Hôpital Henri Mondor	Créteil
France	Département de Chirurgie Cardio-Vasculaire, CHU Le Bocage Dijon Bourgogne	Dijon
France	Département de Chirurgie Vasculaire, CHRU Hôpital Cardiologique de Lille	Lille
France	Département de Chirurgie Vasculaire, Centre Hospitalier Saint Philibert, Lomme	Lomme
France	Hospices Civils de Lyon, Hôpital Edouard Herriot	Lyon
France	Département de Chirurgie Vasculaire, CHU Marseille - Hôpital la Timone	Marseille
France	Département de Chirurgie Vasculaire, CHU Nantes - Hôpital Nord Laënnec	Nantes
France	Département de Chirurgie Vasculaire, CHU Nice - Hôpital Pasteur	Nice
France	APHP Hôpital Bichat - Claude Bernard	Paris
France	Département de Chirurgie Vasculaire, APHP Hôpital de la Pitié-Salpêtrière	Paris
France	Service de Chirurgie Vasculaire	Paris
France	Hopital Lyon Sud	Pierre-Bénite
France	Département de Chirurgie Vasculaire, CHU Poitiers - Hôpital Jean Bernard	Poitiers
France	Département de Chirurgie Vasculaire, CHU Pontchailloux Rennes	Rennes
France	Département de Chirurgie Vasculaire, CHU de Rouen	Rouen
France	Département de Chirurgie Cardio-Vasculaire, CHU Saint Etienne - Hôpital Nord	Saint-Priest-en-Jarez
France	Département de Chirurgie Vasculaire, CHU Amiens Picardie - Site Sud	Salouël
France	Service de Chirurgie Vasculaire, CHU de Strasbourg, Nouvel Hôpital Civil	Strasbourg
France	Département de Chirurgie Vasculaire, CHU Toulouse - Hôpital Rangueil	Toulouse
France	Département de Chirurgie Vasculaire? CHU Nancy - Hôpital Brabois	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months after the primary endovascular treatment
Secondary	Occurrence of endovascular procedure complications		up to discharge from hospital
Secondary	Number of patients with maintained primary, primary assisted and secondary patencies		24 months after the primary endovascular treatment
Secondary	Number of patients with maintained primary, primary assisted and secondary patencies		6 months after the primary endovascular treatment
Secondary	Number of patients with maintained primary, primary assisted and secondary patencies		12 months after the primary endovascular treatment
Secondary	Number of patients with maintained primary, primary assisted and secondary patencies		18 months after the primary endovascular treatment
Secondary	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	24 months after the primary endovascular treatment
Secondary	Freedom of symptoms recurrence	Clinical recurrence, defined as the symptomatic recurrence of chronic, subacute or acute mesenteric ischemia	24 months after the primary endovascular treatment
Secondary	Freedom of reintervention (endovascular or surgical)		24 months after the primary endovascular treatment
Secondary	Occurrence of major morbidity	Occurrence of major morbidity and description of the events	24 months after the primary endovascular treatment
Secondary	Quality of life score	quality of life will be compared between the two groups and assessed using the SF-36 questionnaire	24 months after the primary endovascular treatment
Secondary	Quality of life score	quality of life will be compared between the two groups and assessed using the SF-36 questionnaire	at inclusion
Secondary	Quality of life score	quality of life will be compared between the two groups and assessed using the SF-36 questionnaire	6 months after the primary endovascular treatment
Secondary	Quality of life score	quality of life will be compared between the two groups and assessed using the SF-36 questionnaire	12 months after the primary endovascular treatment
Secondary	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.	12 months after the primary endovascular treatment