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

NCT03383666 | Terminated Phase 3 Results DMC FDA Device

• 1 other identifier: CSC_2017-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Unruptured Wide-neck Intracranial Aneurysms

Keywords

Unruptured; intracranial aneurysms; Endovascular

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Number of Participants With Technical Success of Successful Implantation of the PulseRider Device

  Up to 1 year

• Number of Participants With Target Aneurysms Retreatment

  Up to 1 year

• Number of Participants With Significant Stenosis (>50%) at Implant Site

  Up to 1 year

• Number of Participants With Adequate Aneurysm Occlusion

  1 year

• Number of Participants With Modified Rankin Scale (mRS) 0-2

  1 year

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Device: PulseRider® Aneurysm Neck Reconstruction Device

Interventions

PulseRider® Aneurysm Neck Reconstruction Device DEVICE

Neck Reconstruction Device

Treatment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Pulsar Vascular: lead

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Only 1-year endpoint analyses were performed due to early termination of study enrollment.

Results Point of Contact

• Title: Michael Liao
• Organization: Cerenovus

mliao7@its.jnj.com

510-770-5376

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 26, 2017
• Study Start: October 15, 2018
• Primary Completion: April 12, 2021
• Study Completion: April 12, 2021
• Last Updated: June 6, 2023
• Results First Posted: April 14, 2022

Record last verified: 2023-06

Locations

US (2)