Evaluation of Covered Stents Versus Bare Metal Stents for Endovascular Treatment of Chronic Ischemia Mesenteric Disease.
NCT ID: NCT03586739
Last Updated: 2024-07-03
Study Results
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Basic Information
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COMPLETED
NA
179 participants
INTERVENTIONAL
2018-12-12
2024-04-26
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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"Covered stents" strategy
endovascular angioplasty using covered stents
Primary endovascular angioplasty using one or several covered stents
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.
Short Form-36 (SF-36) questionnaire
The patient will complete a quality-of-life questionnaire (SF-36 form) during their follow up.
"Bare metal stents" strategy
endovascular angioplasty using bare metal stents
Primary endovascular angioplasty using one or several bare metal stents
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.
Short Form-36 (SF-36) questionnaire
The patient will complete a quality-of-life questionnaire (SF-36 form) during their follow up.
Interventions
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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
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.
Short Form-36 (SF-36) questionnaire
The patient will complete a quality-of-life questionnaire (SF-36 form) during their follow up.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Département de Chirurgie Vasculaire, CHU d'Angers
Angers, , France
Département de Chirurgie Vasculaire? CHU J. Minjoz Besançon
Besançon, , 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 Clermont-Ferrand - Hôpital G. Montpied
Clermont-Ferrand, , 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
Département de Chirurgie Vasculaire, CHU Marseille - Hôpital la Timone
Marseille, , France
Département de Chirurgie Vasculaire, CHU Nice - Hôpital Pasteur
Nice, , France
Département de Chirurgie Vasculaire, APHP Hôpital de la Pitié-Salpêtrière
Paris, , France
APHP Hôpital Bichat - Claude Bernard
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 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, , France
Countries
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Other Identifiers
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2018-A01833-52
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL18_0040
Identifier Type: -
Identifier Source: org_study_id
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