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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

Tracking Information
First Submitted Date  ICMJE December 12, 2017
First Posted Date  ICMJE December 26, 2017
Last Update Posted Date January 9, 2019
Actual Study Start Date  ICMJE October 15, 2018
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT03383666 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
Technical Success is measured by the successful implantation of the device. [ Time Frame: Procedural ]
The successful implantation of the device.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Unruptured Wide-neck Intracranial Aneurysms
Intervention  ICMJE Device: PulseRider® Aneurysm Neck Reconstruction Device
Neck Reconstruction Device
Study Arms Experimental: Treatment Group
PulseRider® Aneurysm Neck Reconstruction in conjunction with coil embolization for unruptured wide-neck intracranial aneurysms.
Intervention: Device: PulseRider® Aneurysm Neck Reconstruction Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 22, 2018)
160
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date December 31, 2025
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Lisa Park 949-450-6801 RA-BWIUS-PulseRider@ITS.JNJ.com
Contact: Christopher Hendricks 949-450-6801 RA-BWIUS-PulseRider@ITS.JNJ.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03383666
Other Study ID Numbers  ICMJE CSC_2017-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Pulsar Vascular
Study Sponsor  ICMJE Pulsar Vascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pulsar Vascular
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP