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

NCT02435823 | Completed

• 1 other identifier: CLIN-0015
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Aneurysm

Outcome Measures

Primary Outcomes (3)

• 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

  at the time of the procedure

• Rate of aneurysm occlusion

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

Secondary Outcomes (5)

• Rate of aneurysm occlusion

  at 365-days follow-up

• 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

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

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

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

• Rate of incidence of new neurological deficits

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

• Complication rate (neurological and non-neurological)

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

Study Arms (1)

PulseRider

EXPERIMENTAL

Endovascular treatment of intracranial aneurysms

Device: PulseRider

Interventions

PulseRider DEVICE

Adjunctive device for endovascular embolization of intracranial aneurysms

PulseRider

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 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

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/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

Sponsors & Collaborators

• Pulsar Vascular: lead

Study Sites (1)

Paracelsus Medical University Salzburg

Salzburg, 5020, Austria

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

Study Officials

• Monika Killer, MD

  Paracelsus Medical University

  PRINCIPAL INVESTIGATOR

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: April 28, 2015
• First Posted: May 6, 2015
• Study Start: March 31, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 7, 2019

Record last verified: 2019-02

Locations

AU (1)