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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 (NAPA)

Primary Purpose

Unruptured Wide-neck Intracranial Aneurysms

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PulseRider® Aneurysm Neck Reconstruction Device
Sponsored by
Pulsar Vascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unruptured Wide-neck Intracranial Aneurysms focused on measuring Unruptured, intracranial aneurysms, Endovascular

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Unstable neurological deficit (condition worsening within the last 90 days)
  2. Subarachnoid Hemorrhage (SAH) within the last 60 days
  3. Irreversible bleeding disorder
  4. Patient has another intracranial aneurysm that in the Investigator's opinion, may require treatment within the 1 year follow up period
  5. A history of contrast allergy that cannot be medically controlled
  6. Known allergy to nickel
  7. Relative contraindication to angiography
  8. Woman of child-bearing potential who cannot provide a negative pregnancy test
  9. Current involvement in a study for another investigational product
  10. Patient and / or family considering a move from this geographical location at the time of consent
  11. Categorized as a vulnerable population and require special treatment with respect to safeguards of well-being (e.g. cognitively impaired, veteran, prisoner, etc.)

Sites / Locations

  • University of Kansas Medical Center
  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

PulseRider® Aneurysm Neck Reconstruction in conjunction with coil embolization for unruptured wide-neck intracranial aneurysms.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Number of Participants With Target Aneurysms Retreatment
Number of participants with target aneurysms retreatment were reported.
Number of Participants With Significant Stenosis (>50%) at Implant Site
Number of participants with significant stenosis (>50%) at implant site were reported.
Number of Participants With Adequate Aneurysm Occlusion
Number of participants with adequate aneurysm occlusion were reported.
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.

Full Information

First Posted
December 12, 2017
Last Updated
June 5, 2023
Sponsor
Pulsar Vascular
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1. Study Identification

Unique Protocol Identification Number
NCT03383666
Brief Title
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
Acronym
NAPA
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
No safety issues; change in innovation strategy
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
April 12, 2021 (Actual)
Study Completion Date
April 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pulsar Vascular

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unruptured Wide-neck Intracranial Aneurysms
Keywords
Unruptured, intracranial aneurysms, Endovascular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
PulseRider® Aneurysm Neck Reconstruction in conjunction with coil embolization for unruptured wide-neck intracranial aneurysms.
Intervention Type
Device
Intervention Name(s)
PulseRider® Aneurysm Neck Reconstruction Device
Intervention Description
Neck Reconstruction Device
Primary Outcome Measure Information:
Title
Number of Participants With Complete Aneurysm Occlusion Without Significant Parent Artery Stenosis or Prior Retreatment Through 1 Year Post-Procedure
Description
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.
Time Frame
Up to 1 year post procedure
Title
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)
Description
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.
Time Frame
Up to 1 year post procedure
Secondary Outcome Measure Information:
Title
Number of Participants With Technical Success of Successful Implantation of the PulseRider Device
Description
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.
Time Frame
Up to 1 year
Title
Number of Participants With Target Aneurysms Retreatment
Description
Number of participants with target aneurysms retreatment were reported.
Time Frame
Up to 1 year
Title
Number of Participants With Significant Stenosis (>50%) at Implant Site
Description
Number of participants with significant stenosis (>50%) at implant site were reported.
Time Frame
Up to 1 year
Title
Number of Participants With Adequate Aneurysm Occlusion
Description
Number of participants with adequate aneurysm occlusion were reported.
Time Frame
1 year
Title
Number of Participants With Modified Rankin Scale (mRS) 0-2
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.)
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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