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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)

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ClinicalTrials.gov Identifier: NCT03383666
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Pulsar Vascular

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

Condition or disease Intervention/treatment Phase
Unruptured Wide-neck Intracranial Aneurysms Device: PulseRider® Aneurysm Neck Reconstruction Device Phase 3

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  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. The Primary Safety Outcome measure is the composite of Neurological Death or Major Ipsilateral Stroke (in downstream territory) up to 1 year post-procedure [ Time Frame: 12 months ]
    Composite of Neurological Death or Major Ipsilateral Stroke (in downstream territory) up to 1 year post-procedure.

  2. The primary effectiveness rate of complete aneurysm occlusion without significant parent artery stenosis or prior retreatment at 1 year post-procedure. [ Time Frame: 12 months ]
    The primary effectiveness rate of complete aneurysm occlusion without significant parent artery stenosis or prior retreatment at 1 year post-procedure.


Secondary Outcome Measures :
  1. Technical Success is measured by the successful implantation of the device. [ Time Frame: Procedural ]
    The successful implantation of the device.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383666


Contacts
Contact: Lisa Park 949-450-6801 RA-BWIUS-PulseRider@ITS.JNJ.com
Contact: Christopher Hendricks 949-450-6801 RA-BWIUS-PulseRider@ITS.JNJ.com

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Eric Begemann         
Sponsors and Collaborators
Pulsar Vascular

Responsible Party: Pulsar Vascular
ClinicalTrials.gov Identifier: NCT03383666     History of Changes
Other Study ID Numbers: CSC_2017-01
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Pulsar Vascular:
Unruptured
intracranial aneurysms
Endovascular

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases