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

• Sponsor: Pulsar Vascular (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02312856
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arm: 1
• Actual Duration (Months): 24
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Aneurysms	Device: PulseRider	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and
• Actual Study Start Date: Oct 31, 2014
• Actual Primary Completion Date: Oct 13, 2015
• Actual Study Completion Date: Oct 30, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death [180 days post procedure]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Pulsar Vascular

Investigators

• Principal Investigator: Alejandro Spiotta, MD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pulsar Vascular
• ClinicalTrials.gov Identifier: NCT02312856
• Other Study ID Numbers: CLIN-0014
• First Posted: Dec 9, 2014
• Last Update Posted: Apr 17, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Intracranial Aneurysm; Aneurysm

Study Results

Participant Flow

Arm/Group Title	PulseRider
Arm/Group Description	Subjects 1 year Follow Up
Period Title: Overall Study
STARTED	34
COMPLETED	30
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	PulseRider
Arm/Group Description	Total Participants
Overall Participants	34
Age (year) [Mean (Standard Deviation) ]
Age	60.9 (13.4)
Sex: Female, Male (Count of Participants)
Female	29 85.3%
Male	5 14.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death
Description	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.
Time Frame	180 days post procedure

Outcome Measure Data

Analysis Population Description

One enrolled participant had MRA performed instead of an angiogram and is excluded from Raymond Score analysis.

Arm/Group Title	Safety
Arm/Group Description	Number of affected participants
Measure Participants	34
# participants experienced Neurological Death	0 0%
# participants who scored Raymond Score I/II	29 85.3%

Adverse Events

Time Frame	AEs and SAEs were collected from enrollment of the first subject through 1 year for all subjects.
Adverse Event Reporting Description	All AEs and SAEs were included in the reports to FDA throughout the study.
Arm/Group Title	Number
Arm/Group Description	Number of Participants between the procedure and 365 days
All Cause Mortality
	Number
	Affected / at Risk (%)	# Events
Total	0/34 (0%)
Serious Adverse Events
	Number
	Affected / at Risk (%)	# Events
Total	12/34 (35.3%)
Blood and lymphatic system disorders
Anemia	1/34 (2.9%)	1
Hypotension	1/34 (2.9%)	1
Cardiac disorders
Death	1/34 (2.9%)	1
Stroke	5/34 (14.7%)	5
Musculoskeletal and connective tissue disorders
Leg Fracture	1/34 (2.9%)	1
Weakness	1/34 (2.9%)	1
Nervous system disorders
Cauda Equina Syndrome	1/34 (2.9%)	1
Possible seizure	1/34 (2.9%)	1
Surgical and medical procedures
Coil perforation of aneurysm	1/34 (2.9%)	1
Vascular disorders
Femoral Occlusion	1/34 (2.9%)	1
Other (Not Including Serious) Adverse Events
	Number
	Affected / at Risk (%)	# Events
Total	27/34 (79.4%)
General disorders
Nausea	4/34 (11.8%)	4
Constipation	2/34 (5.9%)	2
Ecchymosis	2/34 (5.9%)	2
Hematoma	2/34 (5.9%)	2
Dizziness	1/34 (2.9%)	1
Nose Bleed	1/34 (2.9%)	1
Infections and infestations
Urinary Tract Infection	2/34 (5.9%)	2
Psychiatric disorders
Depression	2/34 (5.9%)	2
Respiratory, thoracic and mediastinal disorders
Respiratory problems	7/34 (20.6%)	7
Shortness of breath	3/34 (8.8%)	3
Skin and subcutaneous tissue disorders
Itching	1/34 (2.9%)	1
Vascular disorders
Headache	10/34 (29.4%)	10

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.