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Saccular AneurysmEESISNCT02607501

European eCLIPS™ Safety, Feasibility and Efficacy Study

A study testing Implant eCLIPs in people with Saccular Aneurysm and Intracranial Aneurysm, run by Evasc Medical Systems Corp. at 4 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Saccular Aneurysm, Intracranial Aneurysm
What is being tested?
Implant eCLIPs
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
4 sitesin 3 countries
Study dates
1 Apr 2016to 30 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
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  • 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.
  • More than one intracranial aneurysm that requires treatment within 12 months.
  • Asymptomatic extradural aneurysms requiring treatment.
  • Severe neurological deficit that renders the subject incapable of living independently.
  • Unstable neurological deficit (i.e. worsening or improvement of clinical condition in the last 30 days.
  • Dementia or psychiatric problem that prevents the subject from completing required follow up.
  • Subject had a subarachnoid haemorrhage within 6 months prior to enrolment date.
  • Subject has a non-treated arterio-venous malformation in the territory of the target aneurysm.
  • Subject has a need for long-term use of anticoagulants.
  • Patient who is unable to complete the required follow-up.
  • Inability to understand the study or history of non-compliance with medical advice.
  • Evidence of active infection at the time of treatment.
  • Patient who is pregnant or breastfeeding.
  • Patient who has participated in a drug study within the last 30 days.

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Netherlands2 sites

  • Maastricht University Hospital

    Maastricht

  • Radboudumc

    Nijmegen

Other trials in Netherlands

Denmark1 site

  • Aarhus Universitetshospital

    Aarhus

Other trials in Denmark

Germany1 site

  • Universitaetsklinikum Duesseldorf

    Düsseldorf

Other trials in Germany

About this study

Official title: A Multi-center Post Marketing Study Evaluating the Safety, Technical Feasibility, and Efficacy of the eCLIPs™ Family of Products for the Treatment of Bifurcation Intracranial Aneurysms.

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.

Read the detailed description

The objective of this study is to obtain data on the technical feasibility, safety, and efficacy of the eCLIPs™ Products for the treatment of bifurcation aneurysms. Specifically, procedural success of the eCLIPs Bifurcation Remodelling System (BRS) will be evaluated to determine feasibility of this product and safety will be measured as of a major stroke or death within 30 days, or major territorial stroke or neurological death within one year. Additional endpoints will be evaluated and data collected to assess the procedural success of the other eCLIPs Products Microcatheter, Microintroducer, Detacher) and collect efficacy information on the eCLIPs Products. A rate of 69% of aneurysms achieving Raymond Class 1 occlusion at the 12 month endpoint has been chosen as the criterion for success in subjects treated with the eCLIPs Device and coils (primary endpoint).

An upper 95% confidence interval of 10% rate of major ipsilateral stroke or death at the 1 month, and 12 month endpoint has been chosen to demonstrate clinically safety (primary endpoint).

Being tested
Implant eCLIPs
Keywords
coil embolization, bifurcation
Medical subject headings
Aneurysm, Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implant eCLIPsDevice

    Implant eCLIPs at target bifurcation aneurysm

Study groups in NCT02607501
Study groupRoleWhat they receive
eCLIPs BRSOtherImplant eCLIPs BRS at target aneurysm
Receives: Device: Implant eCLIPs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 days

  2. 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.

    Measured: 31 days to 12 months

  3. 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.

    Measured: 6 months

  4. 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.

    Measured: 12 months

Secondary outcomes (9)

  1. eCLIPs Bifurcation Remodeling System Technical Success

    measured by the proportion of successful eCLIPs Device implants at the target aneurysm

    Measured: Procedural

  2. Complete or near complete (Raymond 1 and 2)

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

    Measured: 6 and 12 months

  3. Degree of Flow Diversion (reduction of blood flow into aneurysm)

    reduction of blood flow into aneurysm according to the O'Kelly-Marotta (OKM) grading scale

    Measured: immediately after eCLIPs implant, before coiling

  4. Success of adjuvant coiling into aneurysm after successful eCLIPs Device implant

    Success of adjunctive coiling into aneurysm after successful eCLIPs implantation, assessed by the operator.

    Measured: Procedural

  5. Change in Modified Rankin Score

    Change in Modified Rankin Score (mRS) from baseline. The mRS ranges from 0 to 6; lower scores indicate better outcome.

    Measured: from Baseline to 1 month, 6 months and 12 months

  6. Occurrence of unplanned aneurysm re-treatment

    endovascular or surgical repair

    Measured: within 12 months

  7. Assessment of Device Migration

    Frequency of eCLIPs Device migration

    Measured: at 6 months and 12 months

  8. Assessment of artery stenosis at the device location

    Frequency of cases with artery stenosis at the device location

    Measured: at 6 months and 12 months

  9. Assessment of artery patency at the target aneurysm

    Frequency of cases with artery patency at the target aneurysm

    Measured: at 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2015 (estimated)
  2. Study start1 Apr 2016
  3. Primary completion31 Jan 2020
  4. Study completion30 Sep 2021

Why it stopped: Insufficient accrual rate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02607501
Sponsor's protocol ID
CT-15-009
Acronym
EESIS
Status last verified
Nov 2022
First submitted
16 Nov 2015
Last updated
29 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35393338

Questions about this trial

What is this clinical trial studying?

A study testing Implant eCLIPs in people with Saccular Aneurysm and Intracranial Aneurysm, run by Evasc Medical Systems Corp. at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands, Denmark, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Insufficient accrual rate). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety End Point: absence of a major territorial stroke or death (procedural). (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02607501, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.

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