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)

Pulsar Vascular

Status and phase: Terminated; Phase 3

Conditions: Unruptured Wide-neck Intracranial Aneurysms

Treatments: Device: PulseRider® Aneurysm Neck Reconstruction Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT03383666

CSC_2017-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Treatment Group

Experimental group

Description:

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

Treatment:

Device: PulseRider® Aneurysm Neck Reconstruction Device