INSPIRE Pipeline™ Shield Post Approval Study

Recruiting at 15 trial locations

Overseen By Medtronic Neurovascular Clinical Affairs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Neurovascular Clinical Affairs

Disqualifiers: Pregnancy, Breastfeeding, Inaccessible, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Institutional routine clinical care

246 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the Pipeline™ Flex Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Shield PAS") is to collect on-label use data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Flex Embolization Device with Shield Technology™ ("Pipeline™ Shield Device") in a real-world post approval setting within the United States.

Research Team

Harsh Sancheti

Principal Investigator

Medtronic

Eligibility Criteria

Inclusion Criteria

Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.

Patient is consented within the enrollment window of the therapy received, as applicable.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo treatment for intracranial aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™

Institutional routine clinical care

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Pipeline™ Flex Embolization Device with Shield Technology™

Pipeline™ Flex Embolization Device with Shield Technology™ is already approved in United States, European Union for the following indications:

Approved in United States as Pipeline Flex Embolization Device with Shield Technology for:

• Endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments
• Endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysm (IAs) arising from a parent vessel with a diameter 2.0 mm and ≤ 5.0 mm

Approved in European Union as Pipeline Flex Embolization Device with Shield Technology for:

• Endovascular embolization of cerebral aneurysms

Who Is Running the Clinical Trial?

Medtronic Neurovascular Clinical Affairs

Lead Sponsor

Trials

32

Recruited

10,000+