Endovascular Treatment in Ischemic Stroke Follow-up Evaluation (ETIS)
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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: NCT03776877 |
Recruitment Status :
Recruiting
First Posted : December 17, 2018
Last Update Posted : May 26, 2020
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Condition or disease |
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Stroke, Acute |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 4000 participants |
Observational Model: | Cohort |
Time Perspective: | Other |
Target Follow-Up Duration: | 90 Days |
Official Title: | Evaluation of Clinical and Imaging Criteria, and Plasma Biomarkers of Patients Receiving an Endovascular Treatment for an Acute Ischemic Stroke |
Actual Study Start Date : | June 26, 2018 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2022 |

Group/Cohort |
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Arterial Ischemic Stroke (AIS)
All patients (prospective and retrospective) included will have to present an Arterial Ischemic Stroke (AIS) from a large cerebral vessel occlusion. The participation in the study will consist in:
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- Clinical outcome [ Time Frame: Day 90 ]modified Rankin score (mRS), score 0 to 6 with 0 = no symptoms and 6 = death.
- Efficacy on reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b/3) [ Time Frame: Day 1 ]Rate of complete or near complete reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b/3)
- Efficacy on revascularization (>= mTICI 2b) [ Time Frame: Day 1 ]Time to achieve TICI 2b or better revascularization
- Efficacy on clinical outcome (mRS=0-1) [ Time Frame: Day 90 ]Rate of excellent functional outcome defined as a modified Rankin score (mRS) 0-1
- Efficacy on functional independence (mRS 0-2) [ Time Frame: Day 90 ]Rate of functional independence defined as a modified Rankin score 0-2
- Hemorrhage evaluated by imagery [ Time Frame: Day 0 ]Rate of symptomatic and asymptomatic intracerebral hemorrhage at MRI or CT scan
- Hematoma rate [ Time Frame: Day 1 ]Rate of parenchymal hematoma 2
- Mortality rate [ Time Frame: Day 90 ]Rate of all-cause mortality
- Complication rate [ Time Frame: Day 0 ]Rate of periprocedural complications
- ASPECT (Alberta Stroke Program Early CT score) [ Time Frame: Day O ]Measure by Axial imaging, 10-point quantitative topographic CT scan score
- Parametric imaging [ Time Frame: Day 0 ]Diffusion, volume clinical-diffusion mismatch
- Imaging data [ Time Frame: Day 1 ]Angiographic imaging
- Blood sampling for research purpose [ Time Frame: Day 0 ]Search of biomarkers of stroke etiology and recovery

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age 18 and older (i.e., candidates must have had their 18th birthday)
- Neuroimaging demonstrates acute ischemic stroke with large vessel proximal with the use of neuro-thrombectomy devices intended to restore blood flow
- No upper or lower limits of the neurological severity at baseline (NIHSS).
- With or without intravenous thrombolysis
- Oral informed consent (patient and/or trustworthy person)
Non-inclusion Criteria:
- Pregnant or breast-feeding women
- Patient benefiting from a legal protection
- Non-membership of a national insurance scheme

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): NCT03776877
Contact: Elisabeth Hulier-Ammar | +33146251175 | drci-promotion@hopital-foch.com |
France | |
CHU Bordeaux | Recruiting |
Bordeaux, France | |
Contact: Gaultier Marnat, MD gaultier.marnat@chu-bordeaux.fr | |
Principal Investigator: Gaultier Marnat, MD | |
CHU de Caen | Recruiting |
Caen, France | |
Contact: Emmanuel TOUZE, PhD touze-e@chu-caen.fr | |
Principal Investigator: Emmanuel TOUZE, MD | |
Hôpital le Kremlin-Bicètre - APHP | Recruiting |
Le Kremlin-Bicêtre, France | |
Contact: Laurent Spelle, MD laurent.spelle@aphp.fr | |
Principal Investigator: Laurent Spelle, MD | |
CHU Dupuytren | Recruiting |
Limoges, France, 87042 | |
Contact: Charbel MOUNAYER, MD charbel.mounayer@unilim.fr | |
Principal Investigator: Charbel MOUNAYER, MD | |
CHU Lyon | Not yet recruiting |
Lyon, France | |
Contact: Omer Eker, MD Omer.eker@chu-lyon.fr | |
Principal Investigator: Omer Eker, MD | |
CHU Montpellier | Recruiting |
Montpellier, France | |
Contact: Cyril Dargazanli, MD cyril.dargazanli@gmail.com | |
Principal Investigator: Cyril Darganzanli, MD | |
CHU Nancy | Recruiting |
Nancy, France | |
Contact: Benjamin Gory, MD b.gory@chu-nancy.fr | |
Principal Investigator: Benjamin Gory, MD | |
CHU Nantes | Recruiting |
Nantes, France | |
Contact: Romain Bourcier, MD Romain.bourcier@chu-nantes.fr | |
Principal Investigator: Romain Bourcier, MD | |
Hôpital Pitié Salpétrière | Recruiting |
Paris, France, 75013 | |
Contact: Frédéric CLARENCON, MD frederic.clarencon@aphp.fr | |
Principal Investigator: Frédéric CLARENCON, MD | |
Hôpital SAINTE ANNE | Recruiting |
Paris, France, 75014 | |
Contact: Olivier NAGARRA, MD O.NAGGARA@ch-sainte-anne.fr | |
Principal Investigator: Olivier NAGARRA, MD | |
Fondation Ophtalmique de Rotschild | Recruiting |
Paris, France | |
Contact: Raphael Blanc, MD rblanc@fo-rothschild.fr | |
Principal Investigator: Raphael Blanc, MD | |
CHU Rennes | Recruiting |
Rennes, France | |
Contact: Jean-Christophe Ferre, MD Jean-christophe.FERRE@chu-rennes.fr | |
Principal Investigator: JC Ferre, MD | |
Chu Rouen | Recruiting |
Rouen, France, 76100 | |
Contact: Olzem OZKUL-WERMESTER, MD Ozlem.OzkulWermester@chu-rouen.fr | |
Principal Investigator: Olzem OZKUL-WERMESTER, MD | |
Hôpital Foch | Recruiting |
Suresnes, France, 92150 | |
Contact: Bertrand Lapergue, MD +33(0)1 46 25 73 43 b.lapergue@hopital-foch.org | |
Principal Investigator: Bertrand Lapergue, MD | |
CHU Toulouse | Recruiting |
Toulouse, France, 31300 | |
Contact: Alain VIGUIER, MD viguier.a@chu-toulouse.fr | |
Principal Investigator: Alain VIGUIER, MD | |
CH Bretagne Atlantique | Active, not recruiting |
Vannes, France, 56017 |
Principal Investigator: | Bertrand Larpergue, MD | Hopital Foch |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hopital Foch |
ClinicalTrials.gov Identifier: | NCT03776877 |
Other Study ID Numbers: |
2017024F |
First Posted: | December 17, 2018 Key Record Dates |
Last Update Posted: | May 26, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Stroke Ischemic Stroke Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |