Clinical trial NCT02312856: Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction
Official title: Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysms
Lead sponsor: Pulsar Vascular
Sponsor class: INDUSTRY
First posted: 2014-12-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death
timeFrame: 180 days post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Alejandro Spiotta, MD
role: PRINCIPAL_INVESTIGATOR
References: