Unruptured Wide-neck Intracranial AneurysmsPhase 3NAPANCT03383666

A Study Evaluating the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm

A Phase 3 study testing PulseRider® Aneurysm Neck Reconstruction Device in people with Unruptured Wide-neck Intracranial Aneurysms, run by Pulsar Vascular at 2 sites in United States.

Terminated

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

Official record

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Trial summary

This is a prospective, multi-center, non-randomized clinical evaluation utilizing the PulseRider® Aneurysm Neck Reconstruction Device. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Unruptured Wide-neck Intracranial Aneurysms
What is being tested?: PulseRider® Aneurysm Neck Reconstruction Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 2 sitesUnited States
Study dates: 15 Oct 2018to 12 Apr 2021
Phase: Phase 3
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject with wide neck intracranial aneurysm located at a bifurcation
The subject is between 18 and 80 years of age the time of consent
Informed consent is obtained and the subject signs the IRB approved consent prior to beginning any study procedures
In the opinion of the treating physician, placement of the PulseRider® device is technically feasible and clinically indicated

Who cannot join

Unstable neurological deficit (condition worsening within the last 90 days)
Subarachnoid Hemorrhage (SAH) within the last 60 days
Irreversible bleeding disorder
Patient has another intracranial aneurysm that in the Investigator's opinion, may require treatment within the 1 year follow up period
A history of contrast allergy that cannot be medically controlled
Known allergy to nickel

Show all 11Show fewer

Relative contraindication to angiography
Woman of child-bearing potential who cannot provide a negative pregnancy test
Current involvement in a study for another investigational product
Patient and / or family considering a move from this geographical location at the time of consent
Categorized as a vulnerable population and require special treatment with respect to safeguards of well-being (e.g. cognitively impaired, veteran, prisoner, etc.)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Kansas Medical Center
Kansas City, Kansas, 66160
Mount Sinai Hospital
New York, New York, 10029

Other trials in United States

About this study

Official title: A Prospective, Multi-center, Single Arm Study to Evaluate the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm

This is a prospective, multi-center, non-randomized clinical evaluation utilizing the PulseRider® Aneurysm Neck Reconstruction Device.

Read the detailed description

The objective of this study is to evaluate the safety and effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device in conjunction with coil embolization in the endovascular treatment of unruptured wide-neck intracranial aneurysms.

Conditions: Unruptured Wide-neck Intracranial Aneurysms
Being tested: PulseRider® Aneurysm Neck Reconstruction Device
Keywords: Unruptured, intracranial aneurysms, Endovascular
Medical subject headings: Intracranial Aneurysm

What participants receive

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

PulseRider® Aneurysm Neck Reconstruction DeviceDevice
Neck Reconstruction Device

Study groups in NCT03383666
Study group	Role	What they receive
Treatment Group	Experimental	PulseRider® Aneurysm Neck Reconstruction in conjunction with coil embolization for unruptured wide-neck intracranial aneurysms. Receives: Device: PulseRider® Aneurysm Neck Reconstruction Device

What is being measured

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

Number of Participants With Complete Aneurysm Occlusion Without Significant Parent Artery Stenosis or Prior Retreatment Through 1 Year Post-Procedure
Number of participants with complete aneurysm occlusion (Raymond I: complete occlusion) without significant parent artery stenosis (greater than [>] 50 percent [%] stenosis) or prior retreatment through 1-year post procedure were reported.
Measured: Up to 1 year post procedure
Percentage of Participants With Occurrence of Neurological Death or Major Ipsilateral Stroke in Downstream Territory up to 1 Year Post-procedure Per Clinical Events Committee (CEC)
Percentage of participants with occurrence of neurological death or major ipsilateral stroke in downstream territory up to 1 year post-procedure per CEC were reported. Major stroke is defined as stroke with symptoms persisting for more than 24 hours and a sudden increase in the National Institutes of Health Stroke Scale (NIHSS) of the subject by greater than or equal to (>=) 4. Major ipsilateral stroke is major stroke in downstream territory.
Measured: Up to 1 year post procedure

Secondary outcomes (5)

Number of Participants With Technical Success of Successful Implantation of the PulseRider Device
Technical success was defined as successful implantation of the PulseRider device- the ability to access the target aneurysm, deploy the device at the aneurysm neck, and detach device successfully. Number of participants with technical success were reported.
Measured: Up to 1 year
Number of Participants With Target Aneurysms Retreatment
Number of participants with target aneurysms retreatment were reported.
Measured: Up to 1 year
Number of Participants With Significant Stenosis (>50%) at Implant Site
Number of participants with significant stenosis (>50%) at implant site were reported.
Measured: Up to 1 year
Number of Participants With Adequate Aneurysm Occlusion
Number of participants with adequate aneurysm occlusion were reported.
Measured: 1 year
Number of Participants With Modified Rankin Scale (mRS) 0-2
Number of participants with modified rankin scale (mRS) 0-2 were reported. The mRS is a scale commonly used to measure the degree of disability or dependence in the daily activities in patients following stroke or other neurologic event and is conducted by qualified personnel. It is a scale with six categories ranging from no symptoms to severe disability and death.
Measured: 1 year

Timeline

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

15 Oct 201812 Apr 2021

First posted26 Dec 2017
Study start15 Oct 2018
Primary completion12 Apr 2021
Study completion12 Apr 2021

Why it stopped: No safety issues; change in innovation strategy

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 Unruptured Wide-neck 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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03383666
Sponsor's protocol ID: CSC_2017-01
Acronym: NAPA
Status last verified: Jun 2023
First submitted: 12 Dec 2017
Last updated: 6 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

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

RecruitingObservational study
Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms
Unruptured Intracranial Aneurysm, Intracranial Bifurcation Aneurysm
Recruiting
Flow Diverter Versus Conventional Endovascular Treatment for Unruptured Wide-Neck Bifurcation Aneurysms (FD-BWA Trial)
Unruptured Intracranial Wide-neck Bifurcation Aneurysms
Active, not recruiting
Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms
Intracranial Aneurysms, Wide Neck Intracranial Aneurysms
Not yet recruitingPhase 1
Study to Evaluate the TUBE Device Ability to Treat Unruptured, Wide-neck or Fusiform Aneurysms
Aneurysm Cerebral

All Unruptured Wide-neck Intracranial Aneurysms trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-center, Single Arm Study to Evaluate the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm
ClinicalTrials.gov ID: NCT03383666
Acronym / sponsor ID: NAPA / CSC_2017-01
Conditions: Unruptured Wide-neck Intracranial Aneurysms
Keywords: Unruptured, intracranial aneurysms, Endovascular
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: No safety issues; change in innovation strategy
Enrolment: 21 participants (actual)
Lead sponsor: Pulsar VascularIndustry (pharma, biotech, devices)
Study start: 15 Oct 2018 (actual)
Primary completion: 12 Apr 2021 (actual)
Study completion: 12 Apr 2021 (actual)
First posted: 26 Dec 2017 (actual)
Results: Posted 14 Apr 2022

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, non-randomized clinical evaluation utilizing the PulseRider® Aneurysm Neck Reconstruction Device.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment Group	Experimental	Device: PulseRider® Aneurysm Neck Reconstruction DevicePulseRider® Aneurysm Neck Reconstruction in conjunction with coil embolization for unruptured wide-neck intracranial aneurysms.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subject with wide neck intracranial aneurysm located at a bifurcation
The subject is between 18 and 80 years of age the time of consent
Informed consent is obtained and the subject signs the IRB approved consent prior to beginning any study procedures
In the opinion of the treating physician, placement of the PulseRider® device is technically feasible and clinically indicated

Key exclusion criteria (11 listed)

Unstable neurological deficit (condition worsening within the last 90 days)
Subarachnoid Hemorrhage (SAH) within the last 60 days
Irreversible bleeding disorder
Patient has another intracranial aneurysm that in the Investigator's opinion, may require treatment within the 1 year follow up period
A history of contrast allergy that cannot be medically controlled

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
PulseRider® Aneurysm Neck Reconstruction DeviceNeck Reconstruction Device	Device	Treatment Group

Primary outcome

Number of Participants With Complete Aneurysm Occlusion Without Significant Parent Artery Stenosis or Prior Retreatment Through 1 Year Post-Procedure
Time frame: Up to 1 year post procedure
Number of participants with complete aneurysm occlusion (Raymond I: complete occlusion) without significant parent artery stenosis (greater than [>] 50 percent [%] stenosis) or prior retreatment through 1-year post procedure were reported.
Percentage of Participants With Occurrence of Neurological Death or Major Ipsilateral Stroke in Downstream Territory up to 1 Year Post-procedure Per Clinical Events Committee (CEC)
Time frame: Up to 1 year post procedure
Percentage of participants with occurrence of neurological death or major ipsilateral stroke in downstream territory up to 1 year post-procedure per CEC were reported. Major stroke is defined as stroke with symptoms persisting for more than 24 hours and a sudden increase in the National Institutes of Health Stroke Scale (NIHSS) of the subject by greater than or equal to (>=) 4. Major ipsilateral stroke is major stroke in downstream territory.

5 secondary outcomes

Number of Participants With Technical Success of Successful Implantation of the PulseRider Device
Time frame: Up to 1 year
Number of Participants With Target Aneurysms Retreatment
Time frame: Up to 1 year
Number of Participants With Significant Stenosis (>50%) at Implant Site
Time frame: Up to 1 year
Number of Participants With Adequate Aneurysm Occlusion
Time frame: 1 year
Number of Participants With Modified Rankin Scale (mRS) 0-2
Time frame: 1 year

Results and safety

Results posted to the registry on 14 Apr 2022, 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 Aneurysm Neck Reconstruction Device	21	17

Primary outcome: Number of Participants With Complete Aneurysm Occlusion Without Significant Parent Artery Stenosis or Prior Retreatment Through 1 Year Post-Procedure

Time frame: Up to 1 year post procedure. Count of participants. Unit: Participants

Measure	PulseRider Aneurysm Neck Reconstruction Device n = 13
Value	10

Population analysed: The Per Protocol (PP) analysis set is defined as all participants successfully implanted with the PulseRider device with no major protocol deviations. Here, N (number of participants analyzed) signifies participants evaluable for this outcome measure.

Primary outcome: Percentage of Participants With Occurrence of Neurological Death or Major Ipsilateral Stroke in Downstream Territory up to 1 Year Post-procedure Per Clinical Events Committee (CEC)

Time frame: Up to 1 year post procedure. Number. Unit: Percentage of Participants

Measure	PulseRider Aneurysm Neck Reconstruction Device n = 17
Major Ipsilateral Stroke in Downstream Territory	0
Neurological Death	0

Population analysed: The modified intent to treat (mITT) analysis set is defined as all enrolled participants in whom treatment with the PulseRider device was attempted as defined by advancement of any portion of the PulseRider device outside of the distal end of the microcatheter inside the participant. Here, N (number of participants analyzed) defined as participants evaluable for this outcome measure.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment up to 1 year post procedure.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PulseRider Aneurysm Neck Reconstruction Device	5 of 21 (23.8%)	13 of 21 (61.9%)	0 of 21

Limitations and caveats (from the sponsor): Only 1-year endpoint analyses were performed due to early termination of study enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Unruptured Wide-neck Intracranial Aneurysms

RecruitingObservational study
Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms
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Recruiting
Flow Diverter Versus Conventional Endovascular Treatment for Unruptured Wide-Neck Bifurcation Aneurysms (FD-BWA Trial)
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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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PulseRider® Aneurysm Neck Reconstruction Device in people with Unruptured Wide-neck Intracranial Aneurysms, run by Pulsar Vascular at 2 sites 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 4 inclusion and 11 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 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2022). 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 With Complete Aneurysm Occlusion Without Significant Parent Artery Stenosis or Prior Retreatment Through 1 Year Post-Procedure (time frame: Up to 1 year post procedure). 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?

On the ClinicalTrials.gov record for NCT03383666.

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 6 Jun 2023.