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

May 26, 2023 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

179

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France, 49100
        • Not yet recruiting
        • Département de Chirurgie Vasculaire, CHU d'Angers
        • Contact:
      • Besançon, France, 25000
        • Recruiting
        • Département de Chirurgie Vasculaire? CHU J. Minjoz Besançon
        • Contact:
      • Bordeaux, France, 33000
        • Recruiting
        • Service de Chirurgie Vasculaire et Générale, CHU de Bordeaux - Hôpital Pellegrin
        • Contact:
      • Boulogne-Billancourt, France, 92100
        • Recruiting
        • Département de Chirurgie Vasculaire, APHP Hôpital Ambroise Paré
        • Contact:
      • Brest, France, 29200
        • Recruiting
        • Service de Chirurgie Vasculaire, CHU de Brest, Hôpital de La Cavale Blanche
        • Contact:
        • Principal Investigator:
          • Pierre Gouny, MD
      • Caen, France, 14033
        • Recruiting
        • Département de Chirurgie Vasculaire, CHU Côte de Nacre Caen
        • Contact:
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • Département de Chirurgie Vasculaire, CHU Clermont-Ferrand - Hôpital G. Montpied
        • Contact:
      • Créteil, France, 94010
        • Withdrawn
        • Département de Chirurgie Vasculaire, APHP Hôpital Henri Mondor
      • Dijon, France, 21000
        • Recruiting
        • Département de Chirurgie Cardio-Vasculaire, CHU Le Bocage Dijon Bourgogne
        • Contact:
      • Lille, France, 59037
        • Recruiting
        • Département de Chirurgie Vasculaire, CHRU Hôpital Cardiologique de Lille
        • Contact:
      • Lomme, France, 59462
        • Recruiting
        • Département de Chirurgie Vasculaire, Centre Hospitalier Saint Philibert, Lomme
        • Contact:
      • Lyon, France, 69437
        • Recruiting
        • Hospices Civils de Lyon, Hôpital Edouard Herriot
        • Contact:
      • Marseille, France, 13385
        • Recruiting
        • Département de Chirurgie Vasculaire, CHU Marseille - Hôpital la Timone
        • Contact:
      • Nantes, France, 44093
        • Withdrawn
        • Département de Chirurgie Vasculaire, CHU Nantes - Hôpital Nord Laënnec
      • Nice, France, 06001
        • Recruiting
        • Département de Chirurgie Vasculaire, CHU Nice - Hôpital Pasteur
        • Contact:
      • Paris, France, 75651
        • Recruiting
        • Département de Chirurgie Vasculaire, APHP Hôpital de la Pitié-Salpêtrière
        • Contact:
      • Paris, France, 75877
        • Recruiting
        • APHP Hôpital Bichat - Claude Bernard
        • Contact:
        • Principal Investigator:
          • Yves Hervé CASTIER, Pr
      • Paris, France, 75908
        • Not yet recruiting
        • Service de Chirurgie Vasculaire
        • Contact:
        • Principal Investigator:
          • Iannis BEN ABDALLAH, MD
      • Pierre-Bénite, France, 69495
        • Not yet recruiting
        • Hopital Lyon Sud
        • Contact:
        • Principal Investigator:
          • Patrick FEUGIER, PH
      • Poitiers, France, 86021
        • Recruiting
        • Département de Chirurgie Vasculaire, CHU Poitiers - Hôpital Jean Bernard
        • Contact:
        • Principal Investigator:
          • fabrice SCHNEIDER, Pr
      • Rennes, France, 35000
        • Recruiting
        • Département de Chirurgie Vasculaire, CHU Pontchailloux Rennes
        • Contact:
      • Rouen, France, 76000
        • Not yet recruiting
        • Département de Chirurgie Vasculaire, CHU de Rouen
        • Contact:
      • Saint-Priest-en-Jarez, France, 42270
        • Withdrawn
        • Département de Chirurgie Cardio-Vasculaire, CHU Saint Etienne - Hôpital Nord
      • Salouël, France, 80480
        • Recruiting
        • Département de Chirurgie Vasculaire, CHU Amiens Picardie - Site Sud
        • Contact:
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Chirurgie Vasculaire, CHU de Strasbourg, Nouvel Hôpital Civil
        • Contact:
          • Louis MAGNUS, Dr
      • Toulouse, France, 31059
        • Recruiting
        • Département de Chirurgie Vasculaire, CHU Toulouse - Hôpital Rangueil
        • Contact:
      • Vandœuvre-lès-Nancy, France, 54500
        • Recruiting
        • Département de Chirurgie Vasculaire? CHU Nancy - Hôpital Brabois
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
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.
Procedure: endovascular angioplasty using bare metal stents
Primary endovascular angioplasty using one or several bare metal stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months after the primary endovascular treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of endovascular procedure complications
Time Frame: up to discharge from hospital
up to discharge from hospital
Number of patients with maintained primary, primary assisted and secondary patencies
Time Frame: 24 months after the primary endovascular treatment
24 months after the primary endovascular treatment
Number of patients with maintained primary, primary assisted and secondary patencies
Time Frame: 6 months after the primary endovascular treatment
6 months after the primary endovascular treatment
Number of patients with maintained primary, primary assisted and secondary patencies
Time Frame: 12 months after the primary endovascular treatment
12 months after the primary endovascular treatment
Number of patients with maintained primary, primary assisted and secondary patencies
Time Frame: 18 months after the primary endovascular treatment
18 months after the primary endovascular treatment
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
24 months after the primary endovascular treatment
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
24 months after the primary endovascular treatment
Freedom of reintervention (endovascular or surgical)
Time Frame: 24 months after the primary endovascular treatment
24 months after the primary endovascular treatment
Occurrence of major morbidity
Time Frame: 24 months after the primary endovascular treatment
Occurrence of major morbidity and description of the events
24 months after the primary endovascular treatment
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
24 months after the primary endovascular treatment
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
at inclusion
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
6 months after the primary endovascular treatment
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
12 months after the primary endovascular treatment
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.
12 months after the primary endovascular treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2018

Primary Completion (Estimated)

June 4, 2024

Study Completion (Estimated)

June 4, 2024

Study Registration Dates

First Submitted

July 3, 2018

First Submitted That Met QC Criteria

July 13, 2018

First Posted (Actual)

July 16, 2018

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL18_0040
  • 2018-A01833-52 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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