Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction (ANSWER)

Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and

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

Study Overview

• Status: Completed
• Conditions: Intracranial Aneurysms
• Intervention / Treatment: Device: PulseRider

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)

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PulseRider aneurysm; Endovascular treatment of intracranial aneurysms	Device: PulseRider; Adjunctive device for endovascular embolization of intracranial aneurysms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death	Raymond Scale- an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms. Achieving a Raymond Score I/II. class I: complete obliteration class II: residual neck class III: residual aneurysm class IIIa: contrast opacification within the coil interstices of a residual aneurysm class IIIb: contrast opacification outside the coil interstices, along the residual aneurysm wall. Raymond I is typically associated with better outcomes. The primary outcome of the study looked at safety (death or stroke) and Rate of Aneurysm occlusion (assess by Raymond Roy scores) the two are different. The RR Score is an assessment of occlusion and not used to assess death.	180 days post procedure

Collaborators and Investigators

• Sponsor: Pulsar Vascular
• Investigators: Principal Investigator: Alejandro Spiotta, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 31, 2014
• Primary Completion (ACTUAL): October 13, 2015
• Study Completion (ACTUAL): October 30, 2016

Study Registration Dates

• First Submitted: December 5, 2014
• First Submitted That Met QC Criteria: December 8, 2014
• First Posted (ESTIMATE): December 9, 2014

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CLIN-0014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO