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

NCT03586739 | Completed

• 2 other identifiers: 69HCL18_00402018-A01833-52
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 20

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.

Conditions

Chronic Mesenteric Ischemia; Stent Stenosis

Keywords

Mesenteric Ischemia Chronic; Atherosclerosis; Restenosis; Primary endovascular treatment; Covered stents; Bare metal stents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Occurrence of endovascular procedure complications

  up to discharge from hospital

• Number of patients with maintained primary, primary assisted and secondary patencies

  24 months after the primary endovascular treatment

• Number of patients with maintained primary, primary assisted and secondary patencies

  6 months after the primary endovascular treatment

• Number of patients with maintained primary, primary assisted and secondary patencies

  12 months after the primary endovascular treatment

• Number of patients with maintained primary, primary assisted and secondary patencies

  18 months after the primary endovascular treatment

Study Arms (2)

"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

Interventions

endovascular angioplasty using covered stents PROCEDURE

Primary endovascular angioplasty using one or several covered stents

"Covered stents" strategy

endovascular angioplasty using bare metal stents PROCEDURE

Primary endovascular angioplasty using one or several bare metal stents

"Bare metal stents" strategy

Duplex-scan DEVICE

a Duplex-scan will be performed during patient follow up.

"Bare metal stents" strategy; "Covered stents" strategy

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.

"Bare metal stents" strategy; "Covered stents" strategy

digital angiography DEVICE

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.

"Bare metal stents" strategy; "Covered stents" strategy

Short Form-36 (SF-36) questionnaire OTHER

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

"Bare metal stents" strategy; "Covered stents" strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (20)

Département de Chirurgie Vasculaire, CHU d'Angers

Angers, 49100, France

Location

Département de Chirurgie Vasculaire? CHU J. Minjoz Besançon

Besançon, 25000, France

Location

Département de Chirurgie Vasculaire, APHP Hôpital Ambroise Paré

Boulogne-Billancourt, 92100, France

Location

Service de Chirurgie Vasculaire, CHU de Brest, Hôpital de La Cavale Blanche

Brest, 29200, France

Location

Département de Chirurgie Vasculaire, CHU Clermont-Ferrand - Hôpital G. Montpied

Clermont-Ferrand, 63000, France

Location

Département de Chirurgie Cardio-Vasculaire, CHU Le Bocage Dijon Bourgogne

Dijon, 21000, France

Location

Département de Chirurgie Vasculaire, CHRU Hôpital Cardiologique de Lille

Lille, 59037, France

Location

Département de Chirurgie Vasculaire, Centre Hospitalier Saint Philibert, Lomme

Lomme, 59462, France

Location

Département de Chirurgie Vasculaire, CHU Marseille - Hôpital la Timone

Marseille, 13385, France

Location

Département de Chirurgie Vasculaire, CHU Nice - Hôpital Pasteur

Nice, 06001, France

Location

Département de Chirurgie Vasculaire, APHP Hôpital de la Pitié-Salpêtrière

Paris, 75651, France

Location

APHP Hôpital Bichat - Claude Bernard

Paris, 75877, France

Location

Hopital Lyon Sud

Pierre-Bénite, 69495, France

Location

Département de Chirurgie Vasculaire, CHU Poitiers - Hôpital Jean Bernard

Poitiers, 86021, France

Location

Département de Chirurgie Vasculaire, CHU Pontchailloux Rennes

Rennes, 35000, France

Location

Département de Chirurgie Vasculaire, CHU de Rouen

Rouen, 76000, France

Location

Département de Chirurgie Vasculaire, CHU Amiens Picardie - Site Sud

Salouël, 80480, France

Location

Service de Chirurgie Vasculaire, CHU de Strasbourg, Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

Département de Chirurgie Vasculaire, CHU Toulouse - Hôpital Rangueil

Toulouse, 31059, France

Location

Département de Chirurgie Vasculaire? CHU Nancy - Hôpital Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

Tomography, X-Ray Computed; Angiography, Digital Subtraction; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Angiography; Subtraction Technique; Diagnostic Techniques, Cardiovascular; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 16, 2018
• Study Start: December 12, 2018
• Primary Completion: April 26, 2024
• Study Completion: April 26, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

FR (20)