A Study of the Pipeline™ Vantage Embolization Device With Shield Technology™ for Endovascular Treatment of Wide-Necked Intracranial Aneurysms

Status: Active, not recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to assess the safety and effectiveness of the Pipeline™ Vantage Embolization Device with Shield Technology™ in the treatment of intracranial aneurysms within the intended indication for use.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 80
Healthy Volunteers: No
View:

• Subject has a target intracranial aneurysm located in the internal carotid artery (up to the terminus).

• Subject has a target intracranial aneurysm with an aneurysm neck ≥4mm or a dome-to-neck ratio of < 2.

• Subject has a target intracranial aneurysm that has a parent vessel with diameter 1.5-5.0 mm distal/proximal to the target intracranial aneurysm.

• Subject (or subject's legally authorized representative) has provided written informed consent using the IRB and Medtronic approved Informed Consent Form and agrees to comply with protocol requirements. HIPAA/data protection authorization has been provided and signed by the subject (or subject's legally authorized representative).

• Age 22-80 years at the time of consent.

• Life expectancy ≥3 years

• Subject has a mRS ≤ 2 at baseline to be determined by a certified independent assessor at the site.

• Subject has already been selected for endovascular treatment of the target aneurysm.

• Subject's last recorded P2Y12 reaction units (PRU) value is between ≥60 and ≤200 prior to study procedure. For OUS sites, a Thromboelastogram (TEG) test may be carried out instead of the PRU test (depending on PRU test availability). In cases where TEG test is carried out, the subject should have a pre-procedure therapeutic ADP% between >30% to <90%.

• Subject has multiple increased risk factors for intracranial aneurysm rupture, including but not limited to, aneurysm morphology, smoking, hypertension, diabetes, age, prior and/or family history of rupture, and/or history of subarachnoid hemorrhage that may result in a benefit risk profile of endovascular treatment to outweigh the risks of intracranial aneurysm rupture during the subject's expected lifetime if left untreated.

Locations
United States
Florida
Baptist Medical Center Jacksonville
Jacksonville
Jackson Memorial Hospital
Miami
New York
Stony Brook University Hospital
Stony Brook
Time Frame
Start Date: April 2, 2020
Estimated Completion Date: March 2026
Participants
Target number of participants: 140
Treatments
Experimental: Pipeline™ Vantage Embolization Device with Shield Technology™
Pipeline™ Vantage Embolization Device with Shield Technology™
Related Therapeutic Areas
Sponsors
Leads: Medtronic Neurovascular Clinical Affairs

This content was sourced from clinicaltrials.gov

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