Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction

NCT ID: NCT02312856

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-10-30

Brief Summary

This study is designed to evaluate the safety of the PulseRider in patients undergoing treatment for bifurcation basilar or carotid terminus aneurysms.

Detailed Description

Primary Endpoints:

• Safety: Death or stroke in downstream territory to 180-days post-procedure
• Technical Success: Device placement success and ability to retain coils at the time of the index procedure
• Rate of aneurysm occlusion at Day zero (0) and 180 days

Additional Evaluations to 180-days and at 365-day follow up:

• Rate of aneurysm occlusion at 365 days
• Device movement or migration
• Stenosis
• Rate of incidence of new neurological deficits
• Complication rate (neurological and non-neurological)

Conditions

Intracranial Aneurysms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PulseRider aneurysm

Endovascular treatment of intracranial aneurysms

Group Type: EXPERIMENTAL

PulseRider

Intervention Type: DEVICE

Adjunctive device for endovascular embolization of intracranial aneurysms

Interventions

PulseRider

Adjunctive device for endovascular embolization of intracranial aneurysms

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient who presents with an angiographically confirmed, wide neck intracranial aneurysms located at a bifurcation of the basilar artery or carotid terminus artery
• The target aneurysm is in a vessel with a diameter of 2.7 mm to 4.5 mm.
• The patient is 18 years or older at the time of consent
• The patient has signed the IRB/EC approved informed consent form
• In the opinion of the physician, placement of the PulseRider is technically feasible and clinically indicated
• Subject has mental capacity and is willing and able to comply with protocol requirements and follow-up

Exclusion Criteria

• Unstable neurological deficit (condition worsening within the last 90 days)
• Subarachnoid Hemorrhage (SAH) within the last 60 days
• Irreversible bleeding disorder
• mRS score ≥3
• Patient has another aneurysm which, in the Investigator's opinion, will require treatment within the follow up period (365 days)
• Platelet count < 100 x 103 cells/mm3
• Inability to tolerate, adverse reaction or contraindication to taking aspirin or clopidogrel
• A history of contrast allergy that cannot be medically controlled
• Known allergy to nickel
• Relative contraindication to angiography (e.g., serum creatinine > 2.5 mg/dL)
• Woman with child-bearing potential who cannot provide a negative pregnancy test
• Evidence of active infection
• Other conditions of the heart, blood, brain or intracranial vessels that carry a high risk of neurologic events
• Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 365-day follow-up period
• Extracranial stenosis greater than 50% in the parent artery requiring access to the lesion
• Intracranial stenosis greater than 50% in the treated vessel
• Extreme vessel tortuosity that prohibits appropriate control of the micro-guide wire and/or the PulseRider delivery wire

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pulsar Vascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alejandro Spiotta, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

CLIN-0014

Identifier Type: -

Identifier Source: org_study_id