Intracranial AneurysmsANSWERNCT02312856

Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction

A study testing PulseRider in people with Intracranial Aneurysms, run by Pulsar Vascular at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is designed to evaluate the safety of the PulseRider in patients undergoing treatment for bifurcation basilar or carotid terminus aneurysms. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Intracranial Aneurysms
What is being tested?: PulseRider
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 31 Oct 2014to 30 Oct 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 angiographically confirmed, wide neck intracranial aneurysms located at a bifurcation of the basilar artery or carotid terminus artery
The target aneurysm is in a vessel with a diameter of 2.7 mm to 4.5 mm.
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/mm3

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
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.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and

This study is designed to evaluate the safety of the PulseRider in patients undergoing treatment for bifurcation basilar or carotid terminus 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 at the time of the index procedure
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
Stenosis
Rate of incidence of new neurological deficits
Complication rate (neurological and non-neurological)

Conditions: Intracranial Aneurysms
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 groups in NCT02312856
Study group	Role	What they receive
PulseRider aneurysm	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.

Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death
Raymond Scale- an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms. Achieving a Raymond Score I/II.
class I: complete obliteration class II: residual neck class III: residual aneurysm class IIIa: contrast opacification within the coil interstices of a residual aneurysm class IIIb: contrast opacification outside the coil interstices, along the residual aneurysm wall. Raymond I is typically associated with better outcomes. The primary outcome of the study looked at safety (death or stroke) and Rate of Aneurysm occlusion (assess by Raymond Roy scores) the two are different. The RR Score is an assessment of occlusion and not used to assess death.
Measured: 180 days post procedure

Timeline

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

31 Oct 201430 Oct 2016

First posted9 Dec 2014 (estimated)
Study start31 Oct 2014
Primary completion13 Oct 2015
Study completion30 Oct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02312856
Sponsor's protocol ID: CLIN-0014
Acronym: ANSWER
Status last verified: Apr 2019
First submitted: 5 Dec 2014
Last updated: 17 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Intracranial Aneurysms trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and
ClinicalTrials.gov ID: NCT02312856
Acronym / sponsor ID: ANSWER / CLIN-0014
Conditions: Intracranial Aneurysms
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Pulsar VascularIndustry (pharma, biotech, devices)
Study start: 31 Oct 2014 (actual)
Primary completion: 13 Oct 2015 (actual)
Study completion: 30 Oct 2016 (actual)
First posted: 9 Dec 2014 (estimated)
Results: Posted 26 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is designed to evaluate the safety of the PulseRider in patients undergoing treatment for bifurcation basilar or carotid terminus 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 at the time of the index procedure
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
Stenosis
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 aneurysm	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 angiographically confirmed, wide neck intracranial aneurysms located at a bifurcation of the basilar artery or carotid terminus artery
The target aneurysm is in a vessel with a diameter of 2.7 mm to 4.5 mm.
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 aneurysm

Primary outcome

Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death
Time frame: 180 days post procedure
Raymond Scale- an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms. Achieving a Raymond Score I/II. class I: complete obliteration class II: residual neck class III: residual aneurysm class IIIa: contrast opacification within the coil interstices of a residual aneurysm class IIIb: contrast opacification outside the coil interstices, along the residual aneurysm wall. Raymond I is typically associated with better outcomes. The primary outcome of the study looked at safety (death or stroke) and Rate of Aneurysm occlusion (assess by Raymond Roy scores) the two are different. The RR Score is an assessment of occlusion and not used to assess death.

Results and safety

Results posted to the registry on 26 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PulseRider	34	30

Primary outcome: Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death

Time frame: 180 days post procedure. Number. Unit: Participants

Measure	Safety n = 34
# participants experienced Neurological Death	0
# participants who scored Raymond Score I/II	29

Population analysed: One enrolled participant had MRA performed instead of an angiogram and is excluded from Raymond Score analysis.

Adverse events

Time frame: AEs and SAEs were collected from enrollment of the first subject through 1 year for all subjects.. Other adverse events reported at 2.9% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Number	12 of 34 (35.3%)	27 of 34 (79.4%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Intracranial Aneurysms

RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
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RecruitingObservational study
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Intracranial Sacciform Aneurysm
Not yet recruiting
The NUVASCULAR HARBOR Occlusion Device EU Study
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Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
Active, not recruitingPhase 2
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Cerebral Aneurysm

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.

Alejandro Spiotta, MD principal investigator

Medical University of South Carolina

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 Intracranial Aneurysms, run by Pulsar Vascular at 1 site in United States.

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 17 Apr 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 United States. 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?

Yes. Results are posted in the registry (first posted 26 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death (time frame: 180 days post procedure). 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 NCT02312856.

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 17 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.