NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study

Launched by MEDTRONIC NEUROVASCULAR CLINICAL AFFAIRS · Sep 17, 2024

Keywords

ClinConnect Summary

The NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study is looking at a medical device called the Pipeline™ Vantage Embolization Device with Shield Technology™ to help treat patients with intracranial aneurysms. An intracranial aneurysm is a bulge in a blood vessel in the brain that can be serious if it bursts. This study aims to gather information about how safe and effective this device is after it has been approved for use.

To participate in the study, you need to be an adult with an intracranial aneurysm that the Pipeline™ Vantage Device is meant to treat. You’ll also need to give your written consent, and it’s important to ensure that your health will not be harmed by joining the study. The study is not yet recruiting participants, but once it starts, those involved can expect to receive specific care and follow-up to monitor their health and the device's performance. It’s crucial to know that pregnant or breastfeeding women cannot participate, and those enrolled in other studies that might interfere with this one will also be excluded.

Gender

ALL

Eligibility criteria

• 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.