NCT02841098 - " Endarterectomy Combined With Optimal Medical Therapy (OMT) vs OMT Alone in Patients With Asymptomatic Severe Atherosclerotic Carotid Artery Stenosis at Higher-than-average Risk of Ipsilateral Stroke " | Syfrah

Trials Sponsors Conditions Drugs Pricing

Conditions

Asymptomatic Carotid Artery Stenosis

Keywords

Carotid stenosis,stroke,endarterectomy,medical therapy

Outcome Measures

Primary Outcomes (1)

Ipsilateral stroke or procedural stroke or death
Any ipsilateral stroke within 6 years after randomization or procedural (within 30 days after revascularization) stroke or death
M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72

Secondary Outcomes (19)

Any stroke or procedural death
M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72
Any disabling or fatal stroke or procedural death
M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72
Any stroke or TIA or procedural death
M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72
Any stroke or death
M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72
Myocardial infarction
M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72
+14 more secondary outcomes

Study Arms (2)

Carotid endarterectomy combined with optimal medical therapy

EXPERIMENTAL

Carotid endarterectomy (CEA) combined with optimal medical therapy (OMT)

Other: Carotid endarterectomy (CEA) combined with optimal medical therapy (OMT)

Optimal medical therapy (OMT)

ACTIVE COMPARATOR

Optimal medical therapy (OMT)

Drug: Optimal medical therapy alone

Interventions

Carotid endarterectomy (CEA) combined with optimal medical therapy (OMT)Other

Carotid endarterectomy (CEA) combined with optimal medical therapy (OMT) (Surgery and Drug)

Carotid endarterectomy combined with optimal medical therapy

Optimal medical therapy aloneDrug

Optimal medical therapy alone

Optimal medical therapy (OMT)

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 50 years or over
No ipsilateral stroke or TIA within 180 days of randomization

Sponsors & Collaborators

Hôpitaux Universitaires Paris Ile-de-Franc Ouest
Othercollaborator
Centre Hospitalier St Anne
Otherlead

Study Sites (23)

Centre Hospitalier régional de Besançon, Hôpital Jean Minjoz

Besançon, 25030, France

CHU Bordeaux, Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

CHRU La Cavale Blanche

Brest, 29200, France

Hôpital Gabriel Montpied

Clermont-Ferrand, 63003, France

CHU Henri Mondor

Créteil, 94010, France

CHU Dijon-Bourgogne

Dijon, 21079, France

CHU de Grenoble

Grenoble, 38043, France

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EndarterectomyVascular Surgical Procedures

Study Officials

Jean-Louis MAS
CHSA
STUDY DIRECTOR

Enrollment

43 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

July 19, 2016

First Posted

July 22, 2016

Study Start

September 16, 2019

Actual (reported)