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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PulseRider | Experimental | Endovascular treatment of intracranial aneurysms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PulseRider | Device | Adjunctive device for endovascular embolization of intracranial aneurysms |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monika Killer, MD | Paracelsus Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paracelsus Medical University Salzburg | Salzburg | 5020 | Austria |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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 |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |