Brain AneurysmAWARDNCT02435823
Safety Study of the PulseRider® in Patients Undergoing Treatment for Bifurcation Intracranial Aneurysms
A study testing PulseRider in people with Brain Aneurysm, run by Pulsar Vascular at 1 site in Austria.
Trial summary
This is a prospective multi-center, single arm, non-randomized study. It is designed to evaluate the safety of the PulseRider® in patients undergoing treatment for bifurcation intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Aneurysm
- What is being tested?
- PulseRider
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteAustria
- Study dates
- 31 Mar 2015to 31 Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who presents with an MRA, CTA or angiographically confirmed, wide neck (> 4 mm or dome to neck ratio < 2) intracranial aneurysms located at a bifurcation
- The target aneurysm is in a vessel with a diameter of 2.7 mm to 4.5mm.
- The patient is 18 years or older at the time of consent
- The patient has signed the IRB/EC approved informed consent form
- In the opinion of the physician, placement of the PulseRider is technically feasible and clinically indicated
- Subject has mental capacity and is willing and able to comply with protocol requirements and follow-up
Who cannot join
- Unstable neurological deficit (condition worsening within the last 90 days)
- Subarachnoid Hemorrhage (SAH) within the last 60 days
- Irreversible bleeding disorder
- mRS score ≥3
- Patient has another aneurysm which, in the Investigator's opinion, will require treatment within the follow up period (365 days)
- Platelet count < 100 x 103 cells/mm3or known platelet dysfunction
Show all 17Show fewer
- Inability to tolerate, adverse reaction or contraindication to taking aspirin or clopidogrel
- A history of contrast allergy that cannot be medically controlled
- Known allergy to nickel
- Relative contraindication to angiography (e.g., serum creatinine > 2.5 mg/dL)
- Woman with child-bearing potential who cannot provide a negative pregnancy test
- Evidence of active infection (fever with temperature > 38°C and/or WBC > 15,000)
- Other conditions of the heart, blood, brain or intracranial vessels that carry a high risk of neurologic events
- Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 365-day follow-up period
- Extracranial stenosis greater than 50% in the parent artery requiring access to the lesion
- Intracranial stenosis greater than 50% in the treated vessel
- Extreme vessel tortuosity that prohibits appropriate control of the micro-guide wire and/or the PulseRider delivery wire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjunctive Wide-neck Aneurysm Reconstruction Device Post Market Clinical Study Europe
This is a prospective multi-center, single arm, non-randomized study. It is designed to evaluate the safety of the PulseRider® in patients undergoing treatment for bifurcation intracranial aneurysms.
Read the detailed description
Primary Endpoints:
Safety: Death or stroke in downstream territory to 180-days post-procedure Technical Success: Device placement success and ability to retain coils within the aneurysm (as judged by the treating physician at the time of the procedure. Core lab will review images at a later time) Rate of aneurysm occlusion at Day zero (0) and 180-days
Additional Evaluations to 180-days and at 365-day follow up Rate of aneurysm occlusion at 365 days Device movement or migration defined as any relative change in the position of the device with respect to the parent and/or daughter vessels that is greater than 2mm by conventional catheter angiography, CTA or MRA (180 days) and (365 days) Stenosis defined as >50% at implant site by conventional catheter angiography, MRA or CTA at 180 days and at 365 days Rate of incidence of new neurological deficits Complication rate (neurological and non-neurological)
- Conditions
- Brain Aneurysm
- Being tested
- PulseRider
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulseRiderDevice
Adjunctive device for endovascular embolization of intracranial aneurysms
| Study group | Role | What they receive |
|---|---|---|
| PulseRider | Experimental | Endovascular treatment of intracranial aneurysms Receives: Device: PulseRider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Death or stroke in downstream territory
Measured: to 180-days post-procedure
Technical Success
Device placement success and ability to retain coils within the aneurysm
Measured: at the time of the procedure
Rate of aneurysm occlusion
Measured: Day zero (within 24 hours post procedure) and 180-days
Secondary outcomes (5)
Rate of aneurysm occlusion
Measured: at 365-days follow-up
Device movement or migration defined as any relative change in the position of the device with respect to the parent and/or daughter vessels that is greater than 2mm by conventional catheter angiography, MRA or CTA
Measured: at 180-days follow-up and 365-days follow-up
Stenosis, defined as >50% at implant site by MR angiography or conventional catheter angiography or CTA
Measured: at 180-days follow-up and 365-days follow-up
Rate of incidence of new neurological deficits
Measured: from the time of the procedure to the 365-follow up visit
Complication rate (neurological and non-neurological)
Measured: from the time of the procedure to the 365-follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study start31 Mar 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain AneurysmStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulsar Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monika Killer, MD, Principal investigator, Paracelsus Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435823
- Sponsor's protocol ID
- CLIN-0015
- Acronym
- AWARD
- Status last verified
- Feb 2019
- First submitted
- 28 Apr 2015
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Wide-neck Aneurysm Reconstruction Device Post Market Clinical Study Europe
- ClinicalTrials.gov ID
- NCT02435823
- Acronym / sponsor ID
- AWARD / CLIN-0015
- Conditions
- Brain Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Pulsar VascularIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 6 May 2015 (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.
This is a prospective multi-center, single arm, non-randomized study. It is designed to evaluate the safety of the PulseRider® in patients undergoing treatment for bifurcation intracranial aneurysms.
Detailed description
Primary Endpoints:
Safety: Death or stroke in downstream territory to 180-days post-procedure Technical Success: Device placement success and ability to retain coils within the aneurysm (as judged by the treating physician at the time of the procedure. Core lab will review images at a later time) Rate of aneurysm occlusion at Day zero (0) and 180-days
Additional Evaluations to 180-days and at 365-day follow up Rate of aneurysm occlusion at 365 days Device movement or migration defined as any relative change in the position of the device with respect to the parent and/or daughter vessels that is greater than 2mm by conventional catheter angiography, CTA or MRA (180 days) and (365 days) Stenosis defined as >50% at implant site by conventional catheter angiography, MRA or CTA at 180 days and at 365 days Rate of incidence of new neurological deficits Complication rate (neurological and non-neurological)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PulseRider | Experimental | Device: PulseRiderEndovascular treatment of intracranial aneurysms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient who presents with an MRA, CTA or angiographically confirmed, wide neck (> 4 mm or dome to neck ratio < 2) intracranial aneurysms located at a bifurcation
- The target aneurysm is in a vessel with a diameter of 2.7 mm to 4.5mm.
- The patient is 18 years or older at the time of consent
- The patient has signed the IRB/EC approved informed consent form
- In the opinion of the physician, placement of the PulseRider is technically feasible and clinically indicated
Key exclusion criteria (17 listed)
- Unstable neurological deficit (condition worsening within the last 90 days)
- Subarachnoid Hemorrhage (SAH) within the last 60 days
- Irreversible bleeding disorder
- mRS score ≥3
- Patient has another aneurysm which, in the Investigator's opinion, will require treatment within the follow up period (365 days)
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 |
|---|---|---|
| PulseRiderAdjunctive device for endovascular embolization of intracranial aneurysms | Device | PulseRider |
Primary outcome
Safety: Death or stroke in downstream territory
Time frame: to 180-days post-procedure
Technical Success
Time frame: at the time of the procedure
Device placement success and ability to retain coils within the aneurysm
Rate of aneurysm occlusion
Time frame: Day zero (within 24 hours post procedure) and 180-days
5 secondary outcomes
Rate of aneurysm occlusion
Time frame: at 365-days follow-up
Device movement or migration defined as any relative change in the position of the device with respect to the parent and/or daughter vessels that is greater than 2mm by conventional catheter angiography, MRA or CTA
Time frame: at 180-days follow-up and 365-days follow-up
Stenosis, defined as >50% at implant site by MR angiography or conventional catheter angiography or CTA
Time frame: at 180-days follow-up and 365-days follow-up
Rate of incidence of new neurological deficits
Time frame: from the time of the procedure to the 365-follow up visit
Complication rate (neurological and non-neurological)
Time frame: from the time of the procedure to the 365-follow up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 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.
Monika Killer, MD principal investigator
Paracelsus Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PulseRider in people with Brain Aneurysm, run by Pulsar Vascular at 1 site in Austria.
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 17 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: finished, as of the sponsor's last update on 7 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 1 site in Austria. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Death or stroke in downstream territory (time frame: to 180-days post-procedure). The study lists 3 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 7 Feb 2019.