Informations générales (source: ClinicalTrials.gov)
A Multicentre Post Marketing Study in France Evaluating the Safety and Efficacy of the ECLIPs™ Family of Products for the Treatment of Bifurcation Intracranial Aneurysms At the Carotid and Basilar Terminus (EESIS-Fr)
Interventional
N/A
Evasc Medical Systems Corp. (Voir sur ClinicalTrials)
décembre 2021
avril 2026
20 septembre 2024
The objective of this study is to demonstrate the safety and efficacy of the eCLIPs™
products for the treatment of bifurcation aneurysms.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Raphaël BLANC | 17/12/2024 13:12:55 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - HU Henri-Mondor - Créteil - France | Erwah Kalsoum, MD | Contact (sur clinicalTrials) | |||
| AP-HP - HU Pitié-Salpêtrière - Charles Foix - Paris - France | Nader Sourour, MD | Contact (sur clinicalTrials) | |||
| CH de Colmar - Hôpital Louis Pasteur - Colmar - France | Pablo Ariel Lebedinsky, MD | Contact (sur clinicalTrials) | |||
| CH Sainte-Anne - Paris - France | Olivier Naggara, MD | Contact (sur clinicalTrials) | |||
| CHI Toulon - Toulon - France | Sébastien Gazzola, MD | Contact (sur clinicalTrials) | |||
| CHRU de Brest - Hôpital Cavale Blanche - Brest - France | Jean-Christophe Gentric, MD | Contact (sur clinicalTrials) | |||
| CHRU de Nancy - Hôpital Central - Nancy - France | René Anxionnat, MD | Contact (sur clinicalTrials) | |||
| CHRU de Rennes -Hôpital Pontchaillou - Rennes - France | Quentin Alias, MD | Contact (sur clinicalTrials) | |||
| CHRU de Tours - Bretonneau - Tours - France | Kevin Janot, MD | Contact (sur clinicalTrials) | |||
| CHU d'Amiens - Amiens - France | Cyril Chivot, MD | Contact (sur clinicalTrials) | |||
| CHU de Caen Normandie - Caen - France | Charlotte Barbier, MD | Contact (sur clinicalTrials) | |||
| CHU de Limoges - Limoges - France | Charbel Mounayer, MD | Contact (sur clinicalTrials) | |||
| CHU de Montpellier - Hôpital Guy de Chauliac - Montpellier - France | Vincent Costalat, MD | Contact (sur clinicalTrials) | |||
| CHU de Nantes - Hôpital Laennec - Saint-Herblain - France | Hubert-Armand Desal, MD | Contact (sur clinicalTrials) | |||
| CHU de Nice - Hôpital Pasteur - Nice - France | Yves Chau, MD | Contact (sur clinicalTrials) | |||
| CHU de Poitiers - Poitiers - France | Samy Boucebci, MD | Contact (sur clinicalTrials) | |||
| CHU de Rouen - Rouen - France | Chrysanthi Papagiannaki, MD | Contact (sur clinicalTrials) | |||
| CHU Grenoble Alpes - Grenoble - France | Kamel Boubagra, MD | Contact (sur clinicalTrials) | |||
| Clinique des Cèdres - Cornebarrieu - France | Pierre Guedin, MD | Contact (sur clinicalTrials) | |||
| Groupe Hospitalier Pellegrin - Bordeaux - France | Jérôme Berge, MD | Contact (sur clinicalTrials) | |||
| HCL - Hôpital Pierre Wertheimer - Bron - France | Omer Eker, MD | Contact (sur clinicalTrials) | |||
| Hôpital Bicêtre - Le Kremlin-Bicêtre - France | Laurent Spelle, MD | Contact (sur clinicalTrials) | |||
| Hôpital de La Timone - Marseille - France | Hervé Brunel, MD | Contact (sur clinicalTrials) | |||
| Hôpital François Mitterrand - Dijon - France | Frédéric Ricolfi, MD | Contact (sur clinicalTrials) | |||
| Hôpital Gabriel Montpied - Clermont-Ferrand - France | Emmanuel Chabert, MD | Contact (sur clinicalTrials) | |||
| Hôpital privé Clairval - Marseille - France | Olivier Levrier, MD | Contact (sur clinicalTrials) | |||
| Hôpitaux Universitaires de Strasbourg - Strasbourg - France | Rémy Beaujeux, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Patient whose age is greater than 18 years old
2. Patient with an unruptured or previously ruptured (at least 1 month from date of
rupture and with partial occlusion of the dome of the aneurysm by endovascular
techniques or by open neurosurgery, and in stable neurological condition-WFNS I and
II with a good recovery to at least to mRS 0-2) saccular, intracranial aneurysm or
recurrent aneurysm, which arises at a bifurcation of Basilar Tip or Carotid Terminus
with a minimal diameter of 5mm and a maximal diameter <25mm, has a neck length of
>4mm or dome:neck ratio <2, branch artery diameters in the range of 2.0mm to 3.25mm
3. Patient aneurysm arises at a bifurcation artery with at least one of the two branch
artery vessels having a diameter between 2.0mm and 3.25mm
4. Patient understands the nature of the procedure and has the capacity to provide
informed consent (including fluency in French language)
5. Patient is willing to have on-site 30- day, 6-month, and 12 month follow-up
evaluations as per standard clinical practice
1. Patient whose age is greater than 18 years old
2. Patient with an unruptured or previously ruptured (at least 1 month from date of
rupture and with partial occlusion of the dome of the aneurysm by endovascular
techniques or by open neurosurgery, and in stable neurological condition-WFNS I and
II with a good recovery to at least to mRS 0-2) saccular, intracranial aneurysm or
recurrent aneurysm, which arises at a bifurcation of Basilar Tip or Carotid Terminus
with a minimal diameter of 5mm and a maximal diameter <25mm, has a neck length of
>4mm or dome:neck ratio <2, branch artery diameters in the range of 2.0mm to 3.25mm
3. Patient aneurysm arises at a bifurcation artery with at least one of the two branch
artery vessels having a diameter between 2.0mm and 3.25mm
4. Patient understands the nature of the procedure and has the capacity to provide
informed consent (including fluency in French language)
5. Patient is willing to have on-site 30- day, 6-month, and 12 month follow-up
evaluations as per standard clinical practice
1. Patient with an aneurysm deemed to be an eligible candidate for surgical clipping by
the investigator
2. Patient who presents with an intracranial mass or currently undergoing radiation
therapy for carcinoma of the head or neck region
3. Major surgery within previous 30 days or planned in the next 120 days after
enrolment
4. Patient with an International Normalized Ratio (INR) ≥ 1.5
5. Patient with serum creatinine level ≥104 µmol/L (or 2.5mg/dL) at time of enrolment
6. Patient with a platelet count ˂100x103 cells/mm3 or known platelet dysfunction at
time of enrolment
7. Patient who has a known cardiac disorder, likely to be associated with
cardio-embolic symptoms such as atrial fibrillation
8. Patient with any condition that, in the opinion of the treating physician, would
place the participant at a high risk of embolic stroke or with any medical
co-morbidity likely to affect the outcome (e.g. pulmonary disease, uncontrolled
diabetes, blood disorders)
9. Patient with known allergies to nickel-titanium metal
10. Patient with known allergies to aspirin, heparin, ticlopidine, clopidogrel,
prasugrel or other anti-platelet or P2Y12 agents or to general anesthesia
11. Subject has resistance to P2Y12 agents based on a validated platelet testing method
(Verify Now, Multiplate or other)
12. Patient with a life threatening allergy to contrast (patients with itching or rash
as a reaction to contrast can be included if properly prophylactically treated)
13. Patient with inappropriate anatomy as demonstrated by angiography due to severe
intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive
to medical therapy
14. Patient who is currently participating in another clinical research study involving
an investigational product
15. Patient who has had a previous intracranial procedure associated with the target
aneurysm such that access and placement of an eCLIPs™ device would be compromised
16. Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral
artery) or intracranial artery within 30 days prior to the treatment date
17. More than one intracranial aneurysm that requires treatment within 12 months.
18. Asymptomatic extradural aneurysms requiring treatment
19. Severe neurological deficit that renders the subject incapable of living
independently
20. Unstable neurological deficit (i.e. worsening or improvement of clinical condition
in the last 30 days
21. Dementia or psychiatric problem that prevents the subject from completing required
follow up
22. Subject had a subarachnoid haemorrhage within 1 month prior to enrolment date
23. Subject has a non-treated arterio-venous malformation in the territory of the target
aneurysm
24. Subject has a need for long-term use of anticoagulants
25. Patient who is unable to complete the required follow-up
26. Inability to understand the study or history of non-compliance with medical advice
27. Evidence of active infection at the time of treatment
28. Patient who is pregnant or breastfeeding
29. Patient who has participated in a drug study within the last 30 days
30. Patient over the age of majority benefiting from legal protection (guardianship,
curatorship, safeguard of justice)