Overview

This trial is active, not recruiting.

Condition intracranial aneurysms
Treatment pulserider
Sponsor Pulsar Vascular
Start date October 2014
End date October 2016
Trial size 30 participants
Trial identifier NCT02312856, CLIN-0014

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Endovascular treatment of intracranial aneurysms
pulserider
Adjunctive device for endovascular embolization of intracranial aneurysms

Primary Outcomes

Measure
Death or stroke in downstream territory
time frame: 180-days post-procedure

Secondary Outcomes

Measure
ability to retain coils within the aneurysm
time frame: time of procedure

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and
Principal investigator Alejandro Spiotta, MD
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)
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Pulsar Vascular.