Clinical trial NCT02435823: Safety Study of the PulseRider® in Patients Undergoing Treatment for Bifurcation Intracranial Aneurysms
Official title: Adjunctive Wide-neck Aneurysm Reconstruction Device Post Market Clinical Study Europe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Aneurysm
Lead sponsor: Pulsar Vascular
Sponsor class: INDUSTRY
First posted: 2015-05-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility criteria: Inclusion Criteria:

1. 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
2. The target aneurysm is in a vessel with a diameter of 2.7 mm to 4.5mm.
3. The patient is 18 years or older at the time of consent
4. The patient has signed the IRB/EC approved informed consent form
5. In the opinion of the physician, placement of the PulseRider is technically feasible and clinically indicated
6. Subject has mental capacity and is willing and able to comply with protocol requirements and follow-up

Exclusion Criteria:

1. Unstable neurological deficit (condition worsening within the last 90 days)
2. Subarachnoid Hemorrhage (SAH) within the last 60 days
3. Irreversible bleeding disorder
4. mRS score ≥3
5. Patient has another aneurysm which, in the Investigator's opinion, will require treatment within the follow up period (365 days)
6. Platelet count \< 100 x 103 cells/mm3or known platelet dysfunction
7. Inability to tolerate, adverse reaction or contraindication to taking aspirin or clopidogrel
8. A history of contrast allergy that cannot be medically controlled
9. Known allergy to nickel
10. Relative contraindication to angiography (e.g., serum creatinine \> 2.5 mg/dL)
11. Woman with child-bearing potential who cannot provide a negative pregnancy test
12. Evidence of active infection (fever with temperature \> 38°C and/or WBC \> 15,000)
13. Other conditions of the heart, blood, brain or intracranial vessels that carry a high risk of neurologic events
14. Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 365-day follow-up period
15. Extracranial stenosis greater than 50% in the parent artery requiring access to the lesion
16. Intracranial stenosis greater than 50% in the treated vessel
17. Extreme vessel tortuosity that prohibits appropriate control of the micro-guide wire and/or the PulseRider delivery wire

Primary outcomes:
measure: Safety: Death or stroke in downstream territory
timeFrame: to 180-days post-procedure
measure: Technical Success
timeFrame: at the time of the procedure
measure: Rate of aneurysm occlusion
timeFrame: Day zero (within 24 hours post procedure) and 180-days
Secondary outcomes:
measure: Rate of aneurysm occlusion
timeFrame: at 365-days follow-up
measure: 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
timeFrame: at 180-days follow-up and 365-days follow-up
measure: Stenosis, defined as >50% at implant site by MR angiography or conventional catheter angiography or CTA
timeFrame: at 180-days follow-up and 365-days follow-up
measure: Rate of incidence of new neurological deficits
timeFrame: from the time of the procedure to the 365-follow up visit
measure: Complication rate (neurological and non-neurological)
timeFrame: from the time of the procedure to the 365-follow up visit
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Paracelsus Medical University Salzburg
Study officials:
affiliation: Paracelsus Medical University
name: Monika Killer, MD
role: PRINCIPAL_INVESTIGATOR
References: