French eCLIPs™ Efficacy and Safety Investigation

Intracranial Aneurysm Clinical Trial

— EESIS-Fr  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05330897
• Other study ID #: CT-15-015
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2021
• Est. completion date: April 16, 2026

Study information

• Verified date: September 2023
• Source: Evasc Medical Systems Corp.
• Contact: Donald R Ricci, MD
• Phone: +1.604.961.5335
• Email: donald.ricci[@]evasc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 119
• Est. completion date: April 16, 2026
• Est. primary completion date: April 16, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Procedure:
• Implantation of an eCLIPs™ device
Implantation of an eCLIPs™ device and coiling of the bifurcation aneurysm

Device:
• eCLIPs™ Electrolytic Bifurcation Systems
Implantation of an eCLIPs™ device and coiling of the bifurcation aneurysm

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
Evasc Medical Systems Corp.	European Cardiovascular Research Center

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete aneurysm occlusion with no recurrence or re-treatment	Percent of subjects with complete aneurysm occlusion with no recurrence or re-treatment	12 months
Primary	Major stroke or non-accidental death within 30 days, or major ipsilateral stroke or neurological death between 31 days and 12 months	Percent of subjects with a major stroke or non-accidental death within 30 days or with a major ipsilateral stroke or neurological death between 31 days and 12 months	12 months
Secondary	Technical success	Proportion of successful eCLIPs™ device implants at the target aneurysm	Immediately after the procedure
Secondary	Complete aneurysm occlusion	Percent of subjects with complete aneurysm occlusion at 6 and 24 months	24 months
Secondary	Complete and nearly complete aneurysm occlusion	Percent of subjects with complete and nearly complete aneurysm occlusion at 6, 12 and 24 months	24 months
Secondary	Major ipsilateral stroke or neurological death	Percent of subjects with a major ipsilateral stroke or neurological death	24 months
Secondary	Success of adjuvant coiling into aneurysm after successful eCLIPs™ implant	Proportion of subjects with procedural success for the ability to insert coils into the aneurysm beyond the successfully implanted eCLIPs™ device, and the eCLIPs™ device to satisfactorily retain coils	Immediately after the procedure
Secondary	Modified Rankin Score	Percent of subjects experiencing deterioration of Rankin Score from baseline to 1 month, 6-month, 12-month, and 24-month follow-up	24 months
Secondary	Serious Adverse Device Effects	Percent of subjects experiencing Serious Adverse Device Effects at 1, 6, 12 and 24 months	24 months
Secondary	Unplanned aneurysm re-treatment	Percent of subjects having an unplanned aneurysm re-treatment within 12 or 24 months	24 months
Secondary	Device migration	Proportion of device migration at 12 and 24 months	24 months
Secondary	Artery stenosis	Measurement of artery stenosis by radiography at 6, 12 and 24 months	24 months
Secondary	Artery patency	Qualitative assessment of artery patency at 6, 12 and 24 months	24 months