Pipeline™ Flex Embolization Device with Shield Technology™ for Aneurysm, Ruptured

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Aneurysm, Ruptured+2 More
Pipeline™ Flex Embolization Device with Shield Technology™ - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the safety and effectiveness of the Pipeline Flex Embolization Device with Shield Technology for treating people with aneurysms that have recently ruptured.

Eligible Conditions
  • Aneurysm, Ruptured
  • Berry Aneurysm

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Aneurysm, Ruptured

Study Objectives

2 Primary · 12 Secondary · Reporting Duration: at 30-day, 180-day and 365-day post procedure

Day 0 During Procedure
Pipeline™ Flex Device Deployment Success Rate
at 180-day
Incidence of complete angiographic occlusion without significant stenosis, and no rebleeding or retreatment of the target aneurysm
Incidence of neurological death or disabling stroke post-procedure.
at 30-day, 180-day and 365-day post procedure
Good clinical outcome (modified Rankin Scale (mRS) 0-2)
through 180-day and 365-day post procedure
Incidence of any ipsilateral stroke post-procedure after 30 days
Incidence of ipsilateral major stroke or neurological death post-procedure after 30 days
Incidence of neurological hemorrhagic serious adverse events
Incidence of peri-/post-procedural serious adverse events related to the device, procedure or antiplatelet therapy
Incidence of rebleed of target aneurysm
Incidence of retreatment
through 365-day post procedure
Incidence of complete angiographic occlusion without significant stenosis (≤ 50%), and no rebleeding or retreatment of the target aneurysm
Incidence of in-construct stenosis > 50%
Incidence of neurological death or disabling stroke
Incidence of parent artery thrombosis

Trial Safety

Safety Progress

1 of 3

Other trials for Aneurysm, Ruptured

Trial Design

1 Treatment Group

Pipeline™ Flex Embolization Device with Shield Technology™
1 of 1
Experimental Treatment

200 Total Participants · 1 Treatment Group

Primary Treatment: Pipeline™ Flex Embolization Device with Shield Technology™ · No Placebo Group · N/A

Pipeline™ Flex Embolization Device with Shield Technology™
Device
Experimental Group · 1 Intervention: Pipeline™ Flex Embolization Device with Shield Technology™ · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 30-day, 180-day and 365-day post procedure

Who is running the clinical trial?

Medtronic Neurovascular Clinical AffairsLead Sponsor
30 Previous Clinical Trials
8,537 Total Patients Enrolled
David Fiorella, MDPrincipal InvestigatorStony Brook University Hospital
2 Previous Clinical Trials
330 Total Patients Enrolled
Adam Arthur, MDPrincipal InvestigatorSemmes Murphey Clinic
2 Previous Clinical Trials
330 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The subject has an acutely ruptured aneurysm with Hunt and Hess Scale 1, 2 or 3.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: October 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.