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)

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.

Study Overview

• Status: Terminated
• Conditions: Unruptured Wide-neck Intracranial Aneurysms
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University Of Kansas Medical Center
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; PulseRider® Aneurysm Neck Reconstruction in conjunction with coil embolization for unruptured wide-neck intracranial aneurysms.	Device: PulseRider® Aneurysm Neck Reconstruction Device; Neck Reconstruction Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 1 year post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 1 year
Number of Participants With Target Aneurysms Retreatment	Number of participants with target aneurysms retreatment were reported.	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.	Up to 1 year
Number of Participants With Adequate Aneurysm Occlusion	Number of participants with adequate aneurysm occlusion were reported.	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.	1 year

Collaborators and Investigators

• Sponsor: Pulsar Vascular

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): April 12, 2021
• Study Completion (Actual): April 12, 2021

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: intracranial aneurysms; Endovascular; Unruptured
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CSC_2017-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes