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NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study

Recruitingn/aAges 22 Years - anyAllMedtronic Neurovascular Clinical Affairs
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In plain words

What the trial is, and whether it could suit you

The purpose of the Pipeline™ Vantage Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Vantage PAS") is to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Vantage Embolization Device with Shield Technology™ ("Pipeline™ Vantage Device") in a post approval setting.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patient or legally authorized representative (LAR) has provided written informed consent using the Ethics Board and Medtronic approved Informed Consent Form and agrees to comply with the protocol requirements. HIPAA/data protection authorization has been provided and signed by the patient (or patient's LAR) as applicable per local law. 2. Patient has an intracranial aneurysm intended to be treated with the Pipeline™ Vantage Embolization Device with Shield Technology™. 3. Patient is an adult per local law at time of consent. Exclusion Criteria: 1. Patient with any contraindications for the device or procedure per the Pipeline™ Vantage Device local geography IFU. 2. Patient who may be unable to complete the study follow-up. 3. The Investigator determined that the health of the patient may be compromised by the patient's enrollment. 4. Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study. 5. Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results.
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What it tests

  • Treatment of Intracranial Aneurysms
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Where

10 sites
Baptist Medical Center Jacksonville
Jacksonville, United States
Wellstar Research Institute
Marietta, United States
Endeavor Health
Evanston, United States
Ascension St. Vincent Hospital Indianapolis Goodman Campbell Brain and Spine
Carmel, United States
University of Iowa Hospitals and Clinics
Iowa City, United States
McLaren Healthcare
Flint, United States
Washington University in Saint Louis
St Louis, United States
Buffalo Medical Center
Buffalo, United States

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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