INSPIRE Pipelineā¢ Shield Post Approval Study (NCT05071963) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
INSPIRE Pipelineā¢ Shield Post Approval Study
United States246 participantsStarted 2021-12-20
Plain-language summary
The purpose of the Pipelineā¢ Flex Embolization Device with Shield Technologyā¢ Post Approval Study (PAS) ("Pipelineā¢ Shield PAS") is to collect on-label use data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipelineā¢ Flex Embolization Device with Shield Technologyā¢ ("Pipelineā¢ Shield Device") in a real-world post approval setting within the United States.
Who can participate
Age range22 Years
SexALL
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Inclusion criteria
ā. Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
ā. Patient is intended to receive or be treated with an eligible Medtronic product.
ā. Patient is consented within the enrollment window of the therapy received, as applicable.
ā. 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).
ā. Patient has already been selected for endovascular treatment of the target aneurysm with the Pipelineā¢ Shield Device as the appropriate treatment per the Pipelineā¢ Shield Device Instructions For Use (IFU).
Exclusion criteria
ā. Patient who is, or is expected to be, inaccessible for follow-up.
ā. Participation is excluded by local law.
ā. Patient is currently enrolled or plans to enroll in a concurrent drug/device study that may confound the PSR results (i.e. no required intervention that could affect interpretation of all-around product safety and/or effectiveness).
ā. Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
ā. Patient is contraindicated for the device or procedure per the Pipelineā¢ Shield Device IFU.
What they're measuring
1
Incidence of the composite outcome (Occlusion of the target aneurysm, Significant parent artery stenosis, Retreatment of the target aneurysm) at 1 year post-procedure.
ā. The Investigator determined that the health of the patient may be compromised by the patient's enrollment.
ā. Patient is enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval was obtained from Medtronic.