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

Primary Purpose

Intracranial Aneurysms

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PulseRider

About this trial

This is an interventional treatment trial for Intracranial Aneurysms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PulseRider aneurysm

Arm Description

Endovascular treatment of intracranial aneurysms

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02312856

First Posted

December 5, 2014

Last Updated

April 3, 2019

Sponsor

Pulsar Vascular

1. Study Identification

Unique Protocol Identification Number

NCT02312856

Brief Title

Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction

Acronym

ANSWER

Official Title

Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

October 31, 2014 (Actual)

Primary Completion Date

October 13, 2015 (Actual)

Study Completion Date

October 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pulsar Vascular

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracranial Aneurysms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PulseRider aneurysm

Arm Type

Experimental

Arm Description

Endovascular treatment of intracranial aneurysms

Intervention Type

Device

Intervention Name(s)

PulseRider

Intervention Description

Adjunctive device for endovascular embolization of intracranial aneurysms

Primary Outcome Measure Information:

Title

Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death

Description

Time Frame

180 days post procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alejandro Spiotta, MD

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction

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