French eCLIPs™ Efficacy and Safety Investigation

NCT05330897 | Active Not Recruiting DMC

• 1 other identifier: CT-15-015
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 28

Brief Summary

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

Conditions

Intracranial Aneurysm

Keywords

Bifurcation aneurysm; Basilar tip; Carotid terminus

Outcome Measures

Primary Outcomes (2)

• Complete aneurysm occlusion with no recurrence or re-treatment

  Percent of subjects with complete aneurysm occlusion with no recurrence or re-treatment

  12 months

• 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 Outcomes (11)

• Technical success

  Immediately after the procedure

• Complete aneurysm occlusion

  24 months

• Complete and nearly complete aneurysm occlusion

  24 months

• Major ipsilateral stroke or neurological death

  24 months

• Success of adjuvant coiling into aneurysm after successful eCLIPs™ implant

  Immediately after the procedure

Study Arms (1)

Treatment arm

EXPERIMENTAL

Implantation of an eCLIPs™ device

Procedure: Implantation of an eCLIPs™ device; Device: eCLIPs™ Electrolytic Bifurcation Systems

Interventions

Implantation of an eCLIPs™ device PROCEDURE

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

Treatment arm

eCLIPs™ Electrolytic Bifurcation Systems DEVICE

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

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient whose age is greater than 18 years old
• 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
• 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
• Patient understands the nature of the procedure and has the capacity to provide informed consent (including fluency in French language)
• Patient is willing to have on-site 30- day, 6-month, and 12 month follow-up evaluations as per standard clinical practice

You may not qualify if:

• Patient with an aneurysm deemed to be an eligible candidate for surgical clipping by the investigator
• Patient who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region
• Major surgery within previous 30 days or planned in the next 120 days after enrolment
• Patient with an International Normalized Ratio (INR) ≥ 1.5
• Patient with serum creatinine level ≥104 µmol/L (or 2.5mg/dL) at time of enrolment
• Patient with a platelet count ˂100x103 cells/mm3 or known platelet dysfunction at time of enrolment
• Patient who has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation
• 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)
• Patient with known allergies to nickel-titanium metal
• Patient with known allergies to aspirin, heparin, ticlopidine, clopidogrel, prasugrel or other anti-platelet or P2Y12 agents or to general anesthesia
• Subject has resistance to P2Y12 agents based on a validated platelet testing method (Verify Now, Multiplate or other)
• 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)
• Patient with inappropriate anatomy as demonstrated by angiography due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy
• Patient who is currently participating in another clinical research study involving an investigational product
• 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

Sponsors & Collaborators

• Evasc Medical Systems Corp.: lead
• European Cardiovascular Research Center: collaborator

Study Sites (28)

CHU d'Amiens

Amiens, France

Location

Groupe Hospitalier Pellegrin

Bordeaux, France

Location

CHRU de Brest - Hôpital Cavale Blanche

Brest, France

Location

HCL - Hôpital Pierre Wertheimer

Bron, France

Location

CHU de Caen Normandie

Caen, France

Location

Hôpital Gabriel Montpied

Clermont-Ferrand, France

Location

CH de Colmar - Hôpital Louis Pasteur

Colmar, France

Location

Clinique des Cèdres

Cornebarrieu, France

Location

AP-HP - HU Henri-Mondor

Créteil, France

Location

Hôpital François Mitterrand

Dijon, France

Location

CHU Grenoble Alpes

Grenoble, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Location

CHU de Limoges

Limoges, France

Location

Hôpital de La Timone

Marseille, France

Location

Hôpital privé Clairval

Marseille, France

Location

CHU de Montpellier - Hôpital Guy de Chauliac

Montpellier, France

Location

CHRU de Nancy - Hôpital Central

Nancy, France

Location

CHU de Nice - Hôpital Pasteur

Nice, France

Location

AP-HP - HU Pitié-Salpêtrière - Charles Foix

Paris, France

Location

CH Sainte-Anne

Paris, France

Location

Hôpital Fondation Adolphe de Rothschild

Paris, France

Location

CHU de Poitiers

Poitiers, France

Location

CHRU de Rennes -Hôpital Pontchaillou

Rennes, France

Location

CHU de Rouen

Rouen, France

Location

CHU de Nantes - Hôpital Laennec

Saint-Herblain, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Location

CHI Toulon

Toulon, France

Location

CHRU de Tours - Bretonneau

Tours, France

Location

Related 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.

  PMID: 28798268 BACKGROUND

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Raphaël Blanc, MD

  Hôpital Fondation Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: April 15, 2022
• Study Start: December 16, 2021
• Primary Completion: December 16, 2025
• Study Completion (Estimated): December 16, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

FR (28)