French eCLIPs™ Efficacy and Safety Investigation

NCT ID: NCT05330897

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-16
• Study Completion Date: 2026-12-16

Brief Summary

The objective of this study is to demonstrate the safety and efficacy of the eCLIPs™ products for the treatment of bifurcation aneurysms.

Detailed Description

This study is a multicentre, open label, historically controlled, single-arm safety and efficacy study of the eCLIPs™ products in the management of bifurcated intracranial aneurysms at basilar tip and carotid terminus. Patients with basilar tip and carotid terminus aneurysms are not considered suitable for surgical treatment by the neurovascular community because of the poor outcome in these localizations. Patients included in the study will have saccular intracranial aneurysms that arise at or adjacent to a bifurcation, having a neck length of ≥ 4mm or have a dome:neck ratio <2. Efficacy will be measured as the proportion of aneurysms achieving complete occlusion (Raymond-Roy 1) at 12 months, while safety will be measured as the proportion of patients without a major stroke or non-accidental death within 30 days (procedural) and without a major ipsilateral stroke or neurological death between 31 days and 12 months. Additional endpoints will be evaluated and data collected to assess safety and collect information on the eCLIPs™ family of products.

Conditions

Intracranial Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

Implantation of an eCLIPs™ device

Group Type: EXPERIMENTAL

Implantation of an eCLIPs™ device

Intervention Type: PROCEDURE

Implantation of an eCLIPs™ device and coiling of the bifurcation aneurysm

eCLIPs™ Electrolytic Bifurcation Systems

Intervention Type: DEVICE

Implantation of an eCLIPs™ device and coiling of the bifurcation aneurysm

Interventions

Implantation of an eCLIPs™ device

Implantation of an eCLIPs™ device and coiling of the bifurcation aneurysm

Intervention Type: PROCEDURE

eCLIPs™ Electrolytic Bifurcation Systems

Implantation of an eCLIPs™ device and coiling of the bifurcation aneurysm

Intervention Type: DEVICE

Eligibility Criteria

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

Exclusion Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Cardiovascular Research Center

NETWORK

Sponsor Role: collaborator

Evasc Medical Systems Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raphaël Blanc, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Fondation Adolphe de Rothschild

Locations

CHU d'Amiens

Amiens, , France

Groupe Hospitalier Pellegrin

Bordeaux, , France

CHRU de Brest - Hôpital Cavale Blanche

Brest, , France

HCL - Hôpital Pierre Wertheimer

Bron, , France

CHU de Caen Normandie

Caen, , France

Hôpital Gabriel Montpied

Clermont-Ferrand, , France

CH de Colmar - Hôpital Louis Pasteur

Colmar, , France

Clinique des Cèdres

Cornebarrieu, , France

AP-HP - HU Henri-Mondor

Créteil, , France

Hôpital François Mitterrand

Dijon, , France

CHU Grenoble Alpes

Grenoble, , France

Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

CHU de Limoges

Limoges, , France

Hôpital de La Timone

Marseille, , France

Hôpital privé Clairval

Marseille, , France

CHU de Montpellier - Hôpital Guy de Chauliac

Montpellier, , France

CHRU de Nancy - Hôpital Central

Nancy, , France

CHU de Nice - Hôpital Pasteur

Nice, , France

AP-HP - HU Pitié-Salpêtrière - Charles Foix

Paris, , France

CH Sainte-Anne

Paris, , France

Hôpital Fondation Adolphe de Rothschild

Paris, , France

CHU de Poitiers

Poitiers, , France

CHRU de Rennes -Hôpital Pontchaillou

Rennes, , France

CHU de Rouen

Rouen, , France

CHU de Nantes - Hôpital Laennec

Saint-Herblain, , France

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

CHI Toulon

Toulon, , France

CHRU de Tours - Bretonneau

Tours, , France

Countries

France

References

Fiorella D, Arthur AS, Chiacchierini R, Emery E, Molyneux A, Pierot L. How safe and effective are existing treatments for wide-necked bifurcation aneurysms? Literature-based objective performance criteria for safety and effectiveness. J Neurointerv Surg. 2017 Dec;9(12):1197-1201. doi: 10.1136/neurintsurg-2017-013223. Epub 2017 Aug 10.

Reference Type: BACKGROUND

PMID: 28798268 (View on PubMed)

Other Identifiers

CT-15-015

Identifier Type: -

Identifier Source: org_study_id