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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03586739
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Chronic Mesenteric Ischemia Stent Stenosis Procedure: endovascular angioplasty using covered stents 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Covered Stents Versus Bare Metal Stents for Endovascular Treatment of Chronic Atherosclerotic Mesenteric Arterial Disease:a Randomised Study.
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : August 12, 2022
Estimated Study Completion Date : August 12, 2022

Arm Intervention/treatment
Experimental: "Covered stents" strategy Procedure: endovascular angioplasty using covered stents
Primary endovascular angioplasty using one or several covered stents

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

Device: 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.


Device: 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.

Active Comparator: "Bare metal stents" strategy Procedure: 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.

Device: 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.


Device: 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.




Primary Outcome Measures :
  1. Freedom from restenosis, [ Time Frame: 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 :
  1. Occurrence of endovascular procedure complications [ Time Frame: up to discharge from hospital ]
  2. Number of patients with maintained primary, primary assisted and secondary patencies [ Time Frame: 24 months after the primary endovascular treatment ]
  3. Number of patients with maintained primary, primary assisted and secondary patencies [ Time Frame: 6 months after the primary endovascular treatment ]
  4. Number of patients with maintained primary, primary assisted and secondary patencies [ Time Frame: 12 months after the primary endovascular treatment ]
  5. Number of patients with maintained primary, primary assisted and secondary patencies [ Time Frame: 18 months after the primary endovascular treatment ]
  6. Target lesion revascularisation (TLR) [ Time Frame: 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

  7. Freedom of symptoms recurrence [ Time Frame: 24 months after the primary endovascular treatment ]
    Clinical recurrence, defined as the symptomatic recurrence of chronic, subacute or acute mesenteric ischemia

  8. Freedom of reintervention (endovascular or surgical) [ Time Frame: 24 months after the primary endovascular treatment ]
  9. Occurrence of major morbidity [ Time Frame: 24 months after the primary endovascular treatment ]
    Occurrence of major morbidity and description of the events

  10. Quality of life score [ Time Frame: 24 months after the primary endovascular treatment ]
    quality of life will be compared between the two groups and assessed using the SF-36 questionnaire

  11. Quality of life score [ Time Frame: at inclusion ]
    quality of life will be compared between the two groups and assessed using the SF-36 questionnaire

  12. Quality of life score [ Time Frame: 6 months after the primary endovascular treatment ]
    quality of life will be compared between the two groups and assessed using the SF-36 questionnaire

  13. Quality of life score [ Time Frame: 12 months after the primary endovascular treatment ]
    quality of life will be compared between the two groups and assessed using the SF-36 questionnaire

  14. Freedom from restenosis [ Time Frame: 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586739


Contacts
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Contact: Patrick FEUGIER, Pr 04.78.86.12.72 ext +33 patrickfeugier@hotmail.com
Contact: Soumia BAYARASSOU, Clinical Research Assistant 04 72 11 51 69 ext +33 soumia.bayarassou01@chu-lyon.fr

Locations
Show Show 26 study locations
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03586739    
Other Study ID Numbers: 69HCL18_0040
2018-A01833-52 ( Other Identifier: ID-RCB )
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Mesenteric Ischemia Chronic
Atherosclerosis
Restenosis
Primary endovascular treatment
Covered stents
Bare metal stents
Additional relevant MeSH terms:
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Mesenteric Ischemia
Ischemia
Pathologic Processes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peritoneal Diseases
Vascular Diseases
Cardiovascular Diseases