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

NACompletedINTERVENTIONAL
Enrollment

179

Participants

Timeline

Start Date

December 12, 2018

Primary Completion Date

April 26, 2024

Study Completion Date

April 26, 2024

Conditions
Chronic Mesenteric IschemiaStent Stenosis
Interventions
PROCEDURE

endovascular angioplasty using covered stents

Primary endovascular angioplasty using one or several covered stents

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.

Trial Locations (20)

13385

Département de Chirurgie Vasculaire, CHU Marseille - Hôpital la Timone, Marseille

21000

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

25000

Département de Chirurgie Vasculaire? CHU J. Minjoz Besançon, Besançon

29200

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

31059

Département de Chirurgie Vasculaire, CHU Toulouse - Hôpital Rangueil, Toulouse

35000

Département de Chirurgie Vasculaire, CHU Pontchailloux Rennes, Rennes

49100

Département de Chirurgie Vasculaire, CHU d'Angers, Angers

54500

Département de Chirurgie Vasculaire? CHU Nancy - Hôpital Brabois, Vandœuvre-lès-Nancy

59037

Département de Chirurgie Vasculaire, CHRU Hôpital Cardiologique de Lille, Lille

59462

Département de Chirurgie Vasculaire, Centre Hospitalier Saint Philibert, Lomme, Lomme

63000

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

67091

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

69495

Hopital Lyon Sud, Pierre-Bénite

75651

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

75877

APHP Hôpital Bichat - Claude Bernard, Paris

76000

Département de Chirurgie Vasculaire, CHU de Rouen, Rouen

80480

Département de Chirurgie Vasculaire, CHU Amiens Picardie - Site Sud, Salouël

86021

Département de Chirurgie Vasculaire, CHU Poitiers - Hôpital Jean Bernard, Poitiers

92100

Département de Chirurgie Vasculaire, APHP Hôpital Ambroise Paré, Boulogne-Billancourt

06001

Département de Chirurgie Vasculaire, CHU Nice - Hôpital Pasteur, Nice

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT03586739 - Evaluation of Covered Stents Versus Bare Metal Stents for Endovascular Treatment of Chronic Ischemia Mesenteric Disease. | Biotech Hunter | Biotech Hunter