European eCLIPS™ Safety, Feasibility and Efficacy Study

NCT02607501 | Terminated DMC

• 1 other identifier: CT-15-009
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 4

Brief Summary

An open label, prospective, multicentre, single-arm, post marketing study evaluating the safety, technical feasibility, and efficacy of the eCLIPs™ Family of Products for the treatment of bifurcation intracranial aneurysms.

Conditions

Saccular Aneurysm; Intracranial Aneurysm

Keywords

coil embolization; bifurcation

Outcome Measures

Primary Outcomes (4)

• Safety End Point: absence of a major territorial stroke or death (procedural).

  Major territorial stroke was defined as an ischemic or hemorrhagic stroke resulting in an increase of ≥4 points on the NIH Stroke Scale/Score (NIHSS) and that persisted for \>24 hours. NIHSS ranges from 0 to 4; with lower scores indicating better outcome.

  30 days

• Absence of a major territorial stroke or neurological death

  Major territorial stroke was defined as an ischemic or hemorrhagic stroke resulting in an increase of ≥4 points on the NIH Stroke Scale/Score (NIHSS) and that persisted for \>24 hours. NIHSS ranges from 0 to 4; with lower scores indicating better outcome.

  31 days to 12 months

• Complete aneurysm occlusion (Raymond 1 )

  complete aneurysm occlusion (modified Raymond-Roy classification (mRRc) I), adjudicated by an independent core laboratory. mRRC ranges from 1 to 3b; where lower scores (1) indicate better outcome.

  6 months

• Complete aneurysm occlusion (Raymond 1 )

  complete aneurysm occlusion (modified Raymond-Roy classification (mRRc) I), adjudicated by an independent core laboratory. mRRC ranges from 1 to 3b; where lower scores (1) indicate better outcome.

  12 months

Secondary Outcomes (9)

• eCLIPs Bifurcation Remodeling System Technical Success

  Procedural

• Complete or near complete (Raymond 1 and 2)

  6 and 12 months

• Degree of Flow Diversion (reduction of blood flow into aneurysm)

  immediately after eCLIPs implant, before coiling

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

  Procedural

• Change in Modified Rankin Score

  from Baseline to 1 month, 6 months and 12 months

Study Arms (1)

eCLIPs BRS

OTHER

Implant eCLIPs BRS at target aneurysm

Device: Implant eCLIPs

Interventions

Implant eCLIPs DEVICE

Implant eCLIPs at target bifurcation aneurysm

eCLIPs BRS

Eligibility Criteria

• Age: 19 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 and has a neck length of \> 4mm or dome:neck ratio \<2.
• Patient aneurysm arises at a bifurcation artery with at least one of the two branch artery vessels having a diameter between 1.5mm and 3.25mm
• Patient understands the nature of the procedure and has the capacity to provide informed consent.
• 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 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 Prasugrel 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
• Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to the treatment date.

Sponsors & Collaborators

• Evasc Medical Systems Corp.: lead
• Radboud University Medical Center: collaborator

Study Sites (4)

Aarhus Universitetshospital

Aarhus, Denmark

Location

Universitaetsklinikum Duesseldorf

Düsseldorf, Germany

Location

Maastricht University Hospital

Maastricht, Netherlands

Location

Radboudumc

Nijmegen, Netherlands

Location

Related Publications (1)

• de Vries J, Aquarius R, Sorensen L, Boogaarts HD, Turowski B, van Zwam WH, Marotta TR, Bartels RHMA. Safety and efficacy of the eCLIPs bifurcation remodelling system for the treatment of wide necked bifurcation aneurysms: 1 year results from the European eCLIPs Safety, Feasibility, and Efficacy Study (EESIS). J Neurointerv Surg. 2023 Feb;15(2):163-171. doi: 10.1136/neurintsurg-2021-018460. Epub 2022 Apr 7.

  PMID: 35393338 RESULT

MeSH Terms

Conditions

Aneurysm; Intracranial Aneurysm

Condition Hierarchy (Ancestors)

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

Study Officials

• Joost DeVries, M.D.

  Radboud University Medical Center

  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: November 16, 2015
• First Posted: November 18, 2015
• Study Start: April 1, 2016
• Primary Completion: January 31, 2020
• Study Completion: September 30, 2021
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); DE (1); NL (2)