Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction

NCT02312856 | Completed Results DMC

• 1 other identifier: CLIN-0014
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intracranial Aneurysms

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PulseRider aneurysm

EXPERIMENTAL

Endovascular treatment of intracranial aneurysms

Device: PulseRider

Interventions

PulseRider DEVICE

Adjunctive device for endovascular embolization of intracranial aneurysms

PulseRider aneurysm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pulsar Vascular: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Christopher Hendricks
• Organization: CERENOVUS

chendric@its.jnj.com

415-656-6565

Study Officials

• Alejandro Spiotta, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 9, 2014
• Study Start: October 31, 2014
• Primary Completion: October 13, 2015
• Study Completion: October 30, 2016
• Last Updated: April 17, 2019
• Results First Posted: March 26, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)