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EVA3S: Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis

Primary Purpose

Transient Ischemic Attack, Carotid Stenosis, Atherosclerosis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Carotid angioplasty and stenting with cerebral protection
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Transient Ischemic Attack focused on measuring Prospective, Randomised, Open, Blinded End-point, PROBE Study, Ischemic stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: In brief, patients are eligible if they have experienced a carotid TIA or non disabling stroke within 4 months before randomisation and if they have an atherosclerotic stenosis of the region of the ipsilateral carotid bifurcation of 60% or more, as determined by the North American Symptomatic Carotid Endarterectomy Trial (NASCET) method, that investigators believe is suitable for both carotid endarterectomy and endovascular treatment. The degree of stenosis warranting treatment initially set at 70% or more was subsequently set at 60% or greater to reflect current generally accepted practice in the treatment of symptomatic carotid stenosis. The presence of a 60% or more ipsilateral carotid stenosis has to be confirmed by conventional digital subtraction angiography or the combination of carotid Duplex scanning and magnetic resonance angiography, provided the results of these non-invasive techniques are concordant. Exclusion Criteria: Patients cannot be included if they have a disabling stroke (mRS >=3), a non atherosclerotic carotid disease, a severe intracranial carotid artery stenosis, contra-indications to heparin, ticlopidine or clopidogrel. There is no age limit. The presence of contralateral occlusion and/or the angiographic appearance of the stenotic lesion are not factors in treatment selection. The randomisation algorithm takes centre and degree of stenosis (more or less than 90% stenosis) into account. Patients must be treated as soon as possible after random assignment, in any case within 2 weeks of randomisation.

Sites / Locations

  • Sainte-Anne Hospital: Department of Neurology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Carotid angioplasty and stenting with cerebral protection

Outcomes

Primary Outcome Measures

Any stroke or death within 30 days of the procedure
Any stroke or death within 30 days of the procedure

Secondary Outcome Measures

Clinical: Myocardial infarction within 30 days of the procedure
Clinical: Myocardial infarction within 30 days of the procedure
Other complications within 30 days of the procedure: cerebral (transient ischemic attack [TIA])
Other complications within 30 days of the procedure: cerebral (transient ischemic attack [TIA])
locoregional (e.g. cranial nerve palsy, complications at the site of puncture)
locoregional (e.g. cranial nerve palsy, complications at the site of puncture)
General: Any disabling stroke or death within 30 days of the procedure plus disabling or fatal ipsilateral stroke during the follow-up period
General: Any disabling stroke or death within 30 days of the procedure plus disabling or fatal ipsilateral stroke during the follow-up period
Any stroke or death within 30 days of the procedure plus any stroke (or any stroke or death) during the follow-up period
Any stroke or death within 30 days of the procedure plus any stroke (or any stroke or death) during the follow-up period
TIA during the follow-up period
TIA during the follow-up period
Functional status at the end of the study
Functional status at the end of the study
Anatomical: Carotid restenosis (> 70% on carotid ultrasound)
Anatomical: Carotid restenosis (> 70% on carotid ultrasound)
Integrity of the stent 2 years after the procedure (on cervical radiogram)
Integrity of the stent 2 years after the procedure (on cervical radiogram)

Full Information

First Posted
September 14, 2005
Last Updated
April 29, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00190398
Brief Title
EVA3S: Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis
Official Title
Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate whether carotid angioplasty with stent (CAS) is as safe and effective as carotid surgery in regards to: the risk of stroke and death within 30 days of the procedure; the long-term risk of ipsilateral carotid territory stroke, in patients with recently symptomatic, severe carotid stenosis suitable for both CAS and carotid endarterectomy.
Detailed Description
Findings from two large randomized clinical trials - NASCET and ECST - have established endarterectomy as the standard treatment for severe symptomatic carotid artery stenosis. Compared to endarterectomy, stenting with or without cerebral protection has the advantage of avoiding general anesthesia and incision in the neck that could lead to nerve injury and wound complications. The costs may be less than those of surgery, mainly because of a shorter hospital stay. However, stenting also carries a risk of stroke and local complications. Unlike endarterectomy, which has known long-term benefits, stenting does not remove the atheromatous plaque, and the long-term efficacy of this technique needs also to be assessed. Several trials are in progress in Europe and the United States. We established this trial to evaluate whether stenting is not inferior to endarterectomy concerning (a) the risk of stroke or death within 30 days of procedure and (b) the long-term risk of ipsilateral stroke, in patients with recently symptomatic, severe carotid stenosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Ischemic Attack, Carotid Stenosis, Atherosclerosis
Keywords
Prospective, Randomised, Open, Blinded End-point, PROBE Study, Ischemic stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
900 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Carotid angioplasty and stenting with cerebral protection
Intervention Type
Device
Intervention Name(s)
Carotid angioplasty and stenting with cerebral protection
Intervention Description
Carotid angioplasty and stenting with cerebral protection
Primary Outcome Measure Information:
Title
Any stroke or death within 30 days of the procedure
Description
Any stroke or death within 30 days of the procedure
Time Frame
during de study
Secondary Outcome Measure Information:
Title
Clinical: Myocardial infarction within 30 days of the procedure
Description
Clinical: Myocardial infarction within 30 days of the procedure
Time Frame
during the study
Title
Other complications within 30 days of the procedure: cerebral (transient ischemic attack [TIA])
Description
Other complications within 30 days of the procedure: cerebral (transient ischemic attack [TIA])
Time Frame
during the study
Title
locoregional (e.g. cranial nerve palsy, complications at the site of puncture)
Description
locoregional (e.g. cranial nerve palsy, complications at the site of puncture)
Time Frame
during the study
Title
General: Any disabling stroke or death within 30 days of the procedure plus disabling or fatal ipsilateral stroke during the follow-up period
Description
General: Any disabling stroke or death within 30 days of the procedure plus disabling or fatal ipsilateral stroke during the follow-up period
Time Frame
during the study
Title
Any stroke or death within 30 days of the procedure plus any stroke (or any stroke or death) during the follow-up period
Description
Any stroke or death within 30 days of the procedure plus any stroke (or any stroke or death) during the follow-up period
Time Frame
during the study
Title
TIA during the follow-up period
Description
TIA during the follow-up period
Time Frame
during the study
Title
Functional status at the end of the study
Description
Functional status at the end of the study
Time Frame
during the study
Title
Anatomical: Carotid restenosis (> 70% on carotid ultrasound)
Description
Anatomical: Carotid restenosis (> 70% on carotid ultrasound)
Time Frame
during the study
Title
Integrity of the stent 2 years after the procedure (on cervical radiogram)
Description
Integrity of the stent 2 years after the procedure (on cervical radiogram)
Time Frame
during the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In brief, patients are eligible if they have experienced a carotid TIA or non disabling stroke within 4 months before randomisation and if they have an atherosclerotic stenosis of the region of the ipsilateral carotid bifurcation of 60% or more, as determined by the North American Symptomatic Carotid Endarterectomy Trial (NASCET) method, that investigators believe is suitable for both carotid endarterectomy and endovascular treatment. The degree of stenosis warranting treatment initially set at 70% or more was subsequently set at 60% or greater to reflect current generally accepted practice in the treatment of symptomatic carotid stenosis. The presence of a 60% or more ipsilateral carotid stenosis has to be confirmed by conventional digital subtraction angiography or the combination of carotid Duplex scanning and magnetic resonance angiography, provided the results of these non-invasive techniques are concordant. Exclusion Criteria: Patients cannot be included if they have a disabling stroke (mRS >=3), a non atherosclerotic carotid disease, a severe intracranial carotid artery stenosis, contra-indications to heparin, ticlopidine or clopidogrel. There is no age limit. The presence of contralateral occlusion and/or the angiographic appearance of the stenotic lesion are not factors in treatment selection. The randomisation algorithm takes centre and degree of stenosis (more or less than 90% stenosis) into account. Patients must be treated as soon as possible after random assignment, in any case within 2 weeks of randomisation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis MAS, Pr, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sainte-Anne Hospital: Department of Neurology
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75674 cedex14
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
17050890
Citation
Mas JL, Chatellier G, Beyssen B, Branchereau A, Moulin T, Becquemin JP, Larrue V, Lievre M, Leys D, Bonneville JF, Watelet J, Pruvo JP, Albucher JF, Viguier A, Piquet P, Garnier P, Viader F, Touze E, Giroud M, Hosseini H, Pillet JC, Favrole P, Neau JP, Ducrocq X; EVA-3S Investigators. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med. 2006 Oct 19;355(16):1660-71. doi: 10.1056/NEJMoa061752.
Results Reference
result
PubMed Identifier
33493046
Citation
Howard VJ, Algra A, Howard G, Bonati LH, de Borst GJ, Bulbulia R, Calvet D, Eckstein HH, Fraedrich G, Greving JP, Halliday A, Hendrikse J, Jansen O, Brown MM, Mas JL, Ringleb PA, Brott TG; Carotid Stenosis Trialists' Collaboration. Absence of Consistent Sex Differences in Outcomes From Symptomatic Carotid Endarterectomy and Stenting Randomized Trials. Stroke. 2021 Jan;52(2):416-423. doi: 10.1161/STROKEAHA.120.030184. Epub 2021 Jan 25.
Results Reference
derived
PubMed Identifier
31378071
Citation
Muller MD, von Felten S, Algra A, Becquemin JP, Bulbulia R, Calvet D, Eckstein HH, Fraedrich G, Halliday A, Hendrikse J, Howard G, Gregson J, Jansen O, Brown MM, Mas JL, Brott TG, Ringleb PA, Bonati LH. Secular Trends in Procedural Stroke or Death Risks of Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis. Circ Cardiovasc Interv. 2019 Aug;12(8):e007870. doi: 10.1161/CIRCINTERVENTIONS.119.007870. Epub 2019 Aug 5.
Results Reference
derived
PubMed Identifier
30355202
Citation
Muller MD, von Felten S, Algra A, Becquemin JP, Brown M, Bulbulia R, Calvet D, Eckstein HH, Fraedrich G, Halliday A, Hendrikse J, Gregson J, Howard G, Jansen O, Mas JL, Brott TG, Ringleb PA, Bonati LH; Carotid Stenosis Trialists' Collaboration. Immediate and Delayed Procedural Stroke or Death in Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis. Stroke. 2018 Nov;49(11):2715-2722. doi: 10.1161/STROKEAHA.118.020684.
Results Reference
derived
PubMed Identifier
28455318
Citation
Rantner B, Kollerits B, Roubin GS, Ringleb PA, Jansen O, Howard G, Hendrikse J, Halliday A, Gregson J, Eckstein HH, Calvet D, Bulbulia R, Bonati LH, Becquemin JP, Algra A, Brown MM, Mas JL, Brott TG, Fraedrich G; Carotid Stenosis Trialists' Collaboration. Early Endarterectomy Carries a Lower Procedural Risk Than Early Stenting in Patients With Symptomatic Stenosis of the Internal Carotid Artery: Results From 4 Randomized Controlled Trials. Stroke. 2017 Jun;48(6):1580-1587. doi: 10.1161/STROKEAHA.116.016233. Epub 2017 Apr 28.
Results Reference
derived
PubMed Identifier
25082808
Citation
Mas JL, Arquizan C, Calvet D, Viguier A, Albucher JF, Piquet P, Garnier P, Viader F, Giroud M, Hosseini H, Hinzelin G, Favrole P, Henon H, Neau JP, Ducrocq X, Padovani R, Milandre L, Rouanet F, Wolff V, Saudeau D, Mahagne MH, Sablot D, Amarenco P, Larrue V, Beyssen B, Leys D, Moulin T, Lievre M, Chatellier G; EVA-3S Investigators. Long-term follow-up study of endarterectomy versus angioplasty in patients with symptomatic severe carotid stenosis trial. Stroke. 2014 Sep;45(9):2750-6. doi: 10.1161/STROKEAHA.114.005671. Epub 2014 Jul 31.
Results Reference
derived
PubMed Identifier
23237679
Citation
Rantner B, Goebel G, Bonati LH, Ringleb PA, Mas JL, Fraedrich G; Carotid Stenting Trialists' Collaboration. The risk of carotid artery stenting compared with carotid endarterectomy is greatest in patients treated within 7 days of symptoms. J Vasc Surg. 2013 Mar;57(3):619-626.e2; discussion 625-6. doi: 10.1016/j.jvs.2012.08.107. Epub 2012 Dec 11.
Results Reference
derived
PubMed Identifier
18774745
Citation
Mas JL, Trinquart L, Leys D, Albucher JF, Rousseau H, Viguier A, Bossavy JP, Denis B, Piquet P, Garnier P, Viader F, Touze E, Julia P, Giroud M, Krause D, Hosseini H, Becquemin JP, Hinzelin G, Houdart E, Henon H, Neau JP, Bracard S, Onnient Y, Padovani R, Chatellier G; EVA-3S investigators. Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial: results up to 4 years from a randomised, multicentre trial. Lancet Neurol. 2008 Oct;7(10):885-92. doi: 10.1016/S1474-4422(08)70195-9. Epub 2008 Sep 5.
Results Reference
derived

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EVA3S: Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis

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