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

Brain Aneurysm Clinical Trial

— AWARD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435823
• Other study ID #: CLIN-0015
• Status: Completed
• Phase: N/A
• Start date: March 31, 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: Pulsar Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Brain Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• PulseRider
Adjunctive device for endovascular embolization of intracranial aneurysms

Locations

Country	Name	City	State
Austria	Paracelsus Medical University Salzburg	Salzburg

Sponsors (1)

Lead Sponsor	Collaborator
Pulsar Vascular

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Death or stroke in downstream territory		to 180-days post-procedure
Primary	Technical Success	Device placement success and ability to retain coils within the aneurysm	at the time of the procedure
Primary	Rate of aneurysm occlusion		Day zero (within 24 hours post procedure) and 180-days
Secondary	Rate of aneurysm occlusion		at 365-days follow-up
Secondary	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
Secondary	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
Secondary	Rate of incidence of new neurological deficits		from the time of the procedure to the 365-follow up visit
Secondary	Complication rate (neurological and non-neurological)		from the time of the procedure to the 365-follow up visit