Intracranial AneurysmsPhase 1CESISNCT01957683
Canadian eCLIPs™ Safety and Feasibility Study Protocol
A Phase 1 study testing eCLIPs™ Family of Products in people with Intracranial Aneurysms, run by Evasc Medical Systems Corp. at 5 sites in Canada.
Trial summary
The purpose of this study is to evaluate the safety and feasibility of the eCLIPs™ Family of Products for the treatment of unruptured intracranial bifurcation aneurysms in conjunction with embolization coils. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysms
- What is being tested?
- eCLIPs™ Family of Products
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesCanada
- Study dates
- Jan 2020to Jan 2022
- Phase
- Phase 1
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only patients with the following characteristics are eligible for study entry:
- Patient whose age is between 18 and 80 years old
- Patient with an unruptured, saccular, intracranial aneurysm or recurrent aneurysm, which arises at a bifurcation and has a neck length of ≤ 6mm and aneurysm size of 5-35mm
- 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.
- Patient is willing to have on-site 30- day, and 6-month, follow-up evaluations as per standard clinical practice.
Who cannot join
- Patients with the following characteristics are not eligible for study entry:
- Patient who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
- Patient with an International Normalized Ratio (INR)≥ 1.5.
- Patient with serum creatinine level ≥104 µmol/L 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 cardioembolic symptoms such as AFIB (atrial fibrillation)
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- Patient with any condition which in the opinion of the treating physician would place the participant at a high risk of embolic stroke
- Patient with known allergies to nickel-titanium metal
- Patient with known allergies to aspirin, heparin, ticlopidine, or clopidogrel
- Patient with a life threatening allergy to contrast (unless treatment for allergy is tolerated)
- 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.
- Patient who has had a previous intracranial stenting procedure associated with the target aneurysm.
- Patient who is unable to complete the required follow-up.
- Patient who is pregnant or breastfeeding.
- Patient who has participated in a drug study within the last 30 days.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Hôpital de l'Enfant-Jésus
Québec, G1J 1Z4
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Saint Michael's Hospital
Toronto, Ontario, M5B 1W8
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
Official title: A Multi-center Pilot Study Evaluating the Safety and Feasibility of the eCLIPs™ Family of Products for the Treatment of Unruptured Bifurcation Intracranial Aneurysms
The purpose of this study is to evaluate the safety and feasibility of the eCLIPs™ Family of Products for the treatment of unruptured intracranial bifurcation aneurysms in conjunction with embolization coils.
Read the detailed description
With this other endoluminal stent/device implantation technique to treat intracranial aneurysms in conjunction with embolic coils, the neurovascular device is placed across the aneurysm neck, to act as a bridge to prevent coils from protruding into the parent artery. Stenting may allow to more safely achieve a higher packing density of coils. These effects may improve the rates of complete aneurysm occlusion and enhance the durability of the coiling treatment. The eCLIPs™ device manufactured by Evasc Medical Systems Corp. has a high density 'leaf' which is implanted across the bifurcation aneurysm neck and anchored in one of the branch arteries of the bifurcation and may provide improved bifurcation aneurysm treatment by allowing for a higher packing density of embolic coils implanted behind the eCLIPs™ device and the eCLIPs™ device in combination with embolic coils may reduce the recurrence/retreatment rate by increasing the rate of complete aneurysm occlusion.
- Conditions
- Intracranial Aneurysms
- Being tested
- eCLIPs™ Family of Products
- Keywords
- intracranial aneurysm, bifurcation, wide-neck, saccular, endovascular treatment, coil embolization, stent, bare platinum
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eCLIPs™ Family of ProductsDevice
Also called Bifurcation Remodeling Device, eCLIPs™ Microcatheter, eCLIPs™ Micro-Introducer, eCLIPs™ Detacher
Safety and feasibility of the eCLIPs™ Family of Products for the treatment of unruptured bifurcation intracranial aneurysms
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Device: eCLIPs™ Family of Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
eCLIPs Bifurcation Remodelling System Technical Success
The proportion of successful eCLIPs device implants at the target aneurysm.
Measured: 24 hours
No participant incurs a major stroke or death within 30 days or major territorial stroke or neurological death within 6 months.
A major stroke is defined as a new neurological event that persists for >24 hours and results in a 4 point increase in the NIHSS score compared to baseline or compared to any subsequent lower score.
Measured: 30 day-6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startJan 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
Why it stopped: insufficient funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evasc Medical Systems Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael EB Kelly, PhD, MD, FRCSC, FACS, Principal investigator, Royal University Hospital, Saskatoon, Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957683
- Sponsor's protocol ID
- CS 13-003
- Acronym
- CESIS
- Status last verified
- Feb 2019
- First submitted
- 4 Oct 2013
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Pilot Study Evaluating the Safety and Feasibility of the eCLIPs™ Family of Products for the Treatment of Unruptured Bifurcation Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT01957683
- Acronym / sponsor ID
- CESIS / CS 13-003
- Conditions
- Intracranial Aneurysms
- Keywords
- intracranial aneurysm, bifurcation, wide-neck, saccular, endovascular treatment, coil embolization, stent, bare platinum
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: insufficient funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Evasc Medical Systems Corp.Industry (pharma, biotech, devices)
- Study start
- Jan 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and feasibility of the eCLIPs™ Family of Products for the treatment of unruptured intracranial bifurcation aneurysms in conjunction with embolization coils.
Detailed description
With this other endoluminal stent/device implantation technique to treat intracranial aneurysms in conjunction with embolic coils, the neurovascular device is placed across the aneurysm neck, to act as a bridge to prevent coils from protruding into the parent artery. Stenting may allow to more safely achieve a higher packing density of coils. These effects may improve the rates of complete aneurysm occlusion and enhance the durability of the coiling treatment. The eCLIPs™ device manufactured by Evasc Medical Systems Corp. has a high density 'leaf' which is implanted across the bifurcation aneurysm neck and anchored in one of the branch arteries of the bifurcation and may provide improved bifurcation aneurysm treatment by allowing for a higher packing density of embolic coils implanted behind the eCLIPs™ device and the eCLIPs™ device in combination with embolic coils may reduce the recurrence/retreatment rate by increasing the rate of complete aneurysm occlusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: eCLIPs™ Family of Products |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient whose age is between 18 and 80 years old
- Patient with an unruptured, saccular, intracranial aneurysm or recurrent aneurysm, which arises at a bifurcation and has a neck length of ≤ 6mm and aneurysm size of 5-35mm
- 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.
- Patient is willing to have on-site 30- day, and 6-month, follow-up evaluations as per standard clinical practice.
Key exclusion criteria (16 listed)
- Patient who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
- Patient with an International Normalized Ratio (INR)≥ 1.5.
- Patient with serum creatinine level ≥104 µmol/L 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 cardioembolic symptoms such as AFIB (atrial fibrillation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eCLIPs™ Family of ProductsAlso: Bifurcation Remodeling Device, eCLIPs™ Microcatheter, eCLIPs™ Micro-Introducer, eCLIPs™ DetacherSafety and feasibility of the eCLIPs™ Family of Products for the treatment of unruptured bifurcation intracranial aneurysms | Device | Single Arm |
Primary outcome
eCLIPs Bifurcation Remodelling System Technical Success
Time frame: 24 hours
The proportion of successful eCLIPs device implants at the target aneurysm.
No participant incurs a major stroke or death within 30 days or major territorial stroke or neurological death within 6 months.
Time frame: 30 day-6 month
A major stroke is defined as a new neurological event that persists for >24 hours and results in a 4 point increase in the NIHSS score compared to baseline or compared to any subsequent lower score.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael EB Kelly, PhD, MD, FRCSC, FACS principal investigator
Royal University Hospital, Saskatoon, Saskatchewan
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing eCLIPs™ Family of Products in people with Intracranial Aneurysms, run by Evasc Medical Systems Corp. at 5 sites in Canada.
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 6 inclusion and 16 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: withdrawn, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
eCLIPs Bifurcation Remodelling System Technical Success (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2019.