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

September 8, 2023 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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

119

Phase

  • 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 Locations

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

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
Intervention / Treatment
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

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

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

Evasc Medical Systems Corp.

Collaborators

European Cardiovascular Research Center

Investigators

  • 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)

December 16, 2021

Primary Completion (Estimated)

April 16, 2025

Study Completion (Estimated)

April 16, 2026

Study Registration Dates

First Submitted

March 10, 2022

First Submitted That Met QC Criteria

April 10, 2022

First Posted (Actual)

April 15, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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

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.

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