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Safety Study of the PulseRider® in Patients Undergoing Treatment for Bifurcation Intracranial Aneurysms (AWARD)

Primary Purpose

Brain Aneurysm

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

PulseRider

About this trial

This is an interventional treatment trial for Brain Aneurysm

Eligibility Criteria

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

Inclusion Criteria:

Patient who presents with an MRA, CTA or angiographically confirmed, wide neck (> 4 mm or dome to neck ratio < 2) intracranial aneurysms located at a bifurcation
The target aneurysm is in a vessel with a diameter of 2.7 mm to 4.5mm.
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/mm3or known platelet dysfunction
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 (fever with temperature > 38°C and/or WBC > 15,000)
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

Paracelsus Medical University Salzburg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PulseRider

Arm Description

Endovascular treatment of intracranial aneurysms

Outcomes

Primary Outcome Measures

Safety: Death or stroke in downstream territory

Technical Success

Device placement success and ability to retain coils within the aneurysm

Rate of aneurysm occlusion

Secondary Outcome Measures

Rate of aneurysm occlusion

Device movement or migration defined as any relative change in the position of the device with respect to the parent and/or daughter vessels that is greater than 2mm by conventional catheter angiography, MRA or CTA

Stenosis, defined as >50% at implant site by MR angiography or conventional catheter angiography or CTA

Rate of incidence of new neurological deficits

Complication rate (neurological and non-neurological)

Full Information

NCT ID

NCT02435823

First Posted

April 28, 2015

Last Updated

February 6, 2019

Sponsor

Pulsar Vascular

1. Study Identification

Unique Protocol Identification Number

NCT02435823

Brief Title

Safety Study of the PulseRider® in Patients Undergoing Treatment for Bifurcation Intracranial Aneurysms

Acronym

AWARD

Official Title

Adjunctive Wide-neck Aneurysm Reconstruction Device Post Market Clinical Study Europe

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

March 31, 2015 (Actual)

Primary Completion Date

December 31, 2018 (Actual)

Study Completion Date

December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pulsar Vascular

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a prospective multi-center, single arm, non-randomized study. It is designed to evaluate the safety of the PulseRider® in patients undergoing treatment for bifurcation intracranial 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 within the aneurysm (as judged by the treating physician at the time of the procedure. Core lab will review images at a later time) 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 defined as any relative change in the position of the device with respect to the parent and/or daughter vessels that is greater than 2mm by conventional catheter angiography, CTA or MRA (180 days) and (365 days) Stenosis defined as >50% at implant site by conventional catheter angiography, MRA or CTA at 180 days and at 365 days 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

Brain Aneurysm

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PulseRider

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

Safety: Death or stroke in downstream territory

Time Frame

to 180-days post-procedure

Title

Technical Success

Description

Device placement success and ability to retain coils within the aneurysm

Time Frame

at the time of the procedure

Title

Rate of aneurysm occlusion

Time Frame

Day zero (within 24 hours post procedure) and 180-days

Secondary Outcome Measure Information:

Title

Rate of aneurysm occlusion

Time Frame

at 365-days follow-up

Title

Time Frame

at 180-days follow-up and 365-days follow-up

Title

Stenosis, defined as >50% at implant site by MR angiography or conventional catheter angiography or CTA

Time Frame

at 180-days follow-up and 365-days follow-up

Title

Rate of incidence of new neurological deficits

Time Frame

from the time of the procedure to the 365-follow up visit

Title

Complication rate (neurological and non-neurological)

Time Frame

from the time of the procedure to the 365-follow up visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient who presents with an MRA, CTA or angiographically confirmed, wide neck (> 4 mm or dome to neck ratio < 2) intracranial aneurysms located at a bifurcation The target aneurysm is in a vessel with a diameter of 2.7 mm to 4.5mm. 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/mm3or known platelet dysfunction 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 (fever with temperature > 38°C and/or WBC > 15,000) 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

Monika Killer, MD

Organizational Affiliation

Paracelsus Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Paracelsus Medical University Salzburg

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

Safety Study of the PulseRider® in Patients Undergoing Treatment for Bifurcation Intracranial Aneurysms

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