French eCLIPs™ Efficacy and Safety Investigation (EESIS-Fr)

August 12, 2025 updated by: Evasc Medical Systems Corp.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
119

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Amiens, France
        • CHU d'Amiens
      • Bordeaux, France
        • Groupe Hospitalier Pellegrin
      • Brest, France
        • CHRU de Brest - Hôpital Cavale Blanche
      • Bron, France
        • HCL - Hôpital Pierre Wertheimer
      • Caen, France
        • CHU de Caen Normandie
      • Clermont-Ferrand, France
        • Hôpital Gabriel Montpied
      • Colmar, France
        • CH de Colmar - Hôpital Louis Pasteur
      • Cornebarrieu, France
        • Clinique des Cèdres
      • Créteil, France
        • AP-HP - HU Henri-Mondor
      • Dijon, France
        • Hôpital François Mitterrand
      • Grenoble, France
        • CHU Grenoble Alpes
      • Le Kremlin-Bicêtre, France
        • Hôpital Bicêtre
      • Limoges, France
        • CHU de Limoges
      • Marseille, France
        • Hôpital de la Timone
      • Marseille, France
        • Hôpital Privé Clairval
      • Montpellier, France
        • CHU de Montpellier - Hôpital Guy de Chauliac
      • Nancy, France
        • CHRU de Nancy - Hôpital Central
      • Nice, France
        • CHU de Nice - Hopital Pasteur
      • Paris, France
        • Hôpital Fondation Adolphe de Rothschild
      • Paris, France
        • AP-HP - HU Pitié-Salpêtrière - Charles Foix
      • Paris, France
        • CH Sainte-Anne
      • Poitiers, France
        • CHU De Poitiers
      • Rennes, France
        • CHRU de Rennes -Hôpital Pontchaillou
      • Rouen, France
        • CHU de Rouen
      • Saint-Herblain, France
        • CHU de Nantes - Hopital Laennec
      • Strasbourg, France
        • Hopitaux Universitaires de Strasbourg
      • Toulon, France
        • CHI Toulon
      • Tours, France
        • CHRU de Tours - Bretonneau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment arm
Implantation of an eCLIPs™ device
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete aneurysm occlusion with no recurrence or re-treatment
Time Frame: 12 months
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
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: Immediately after the procedure
Proportion of successful eCLIPs™ device implants at the target aneurysm
Immediately after the procedure
Complete aneurysm occlusion
Time Frame: 24 months
Percent of subjects with complete aneurysm occlusion at 6 and 24 months
24 months
Complete and nearly complete aneurysm occlusion
Time Frame: 24 months
Percent of subjects with complete and nearly complete aneurysm occlusion at 6, 12 and 24 months
24 months
Major ipsilateral stroke or neurological death
Time Frame: 24 months
Percent of subjects with a major ipsilateral stroke or neurological death
24 months
Success of adjuvant coiling into aneurysm after successful eCLIPs™ implant
Time Frame: Immediately after the procedure
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
Modified Rankin Score
Time Frame: 24 months
Percent of subjects experiencing deterioration of Rankin Score from baseline to 1 month, 6-month, 12-month, and 24-month follow-up
24 months
Serious Adverse Device Effects
Time Frame: 24 months
Percent of subjects experiencing Serious Adverse Device Effects at 1, 6, 12 and 24 months
24 months
Unplanned aneurysm re-treatment
Time Frame: 24 months
Percent of subjects having an unplanned aneurysm re-treatment within 12 or 24 months
24 months
Device migration
Time Frame: 24 months
Proportion of device migration at 12 and 24 months
24 months
Artery stenosis
Time Frame: 24 months
Measurement of artery stenosis by radiography at 6, 12 and 24 months
24 months
Artery patency
Time Frame: 24 months
Qualitative assessment of artery patency at 6, 12 and 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Evasc Medical Systems Corp.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
European Cardiovascular Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raphaël Blanc, MD, Hôpital Fondation Adolphe de Rothschild

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT-15-015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings