Clinical trial NCT05071963: INSPIRE Pipeline™ Shield Post Approval Study
Official title: Neurovascular Product Surveillance Registry (INSPIRE) Pipeline™ Flex Embolization Device With Shield Technology™ Post Approval Study (PAS)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intracranial Aneurysm
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2021-10-08
Enrollment: 246
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring treatment for intracranial aneurysms with the market approved Pipeline™ Flex Embolization Device with Shield Technology™ device are eligible for the registry

Brief summary: 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.

Detailed description: The INSPIRE Pipeline™ Shield Post Approval Study is an observational, prospective, multi-center, single-arm registry to collect on-label use data in patients undergoing treatment for intracranial aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™ according to the intended use.

The primary objective of this study is to evaluate the on-label use of the Pipeline™ Shield Device in patients undergoing treatment for intracranial aneurysms per institutional routine clinical care in a real-world post approval study setting in the U.S.

This study is conducted under the Product Surveillance Registry (NCT01524276) and is a sub-study to the therapy specific Neurovascular Product Surveillance Registry (NCT02988128).

Eligibility criteria: Inclusion Criteria:

1. Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
2. Patient is intended to receive or be treated with an eligible Medtronic product.
3. Patient is consented within the enrollment window of the therapy received, as applicable.
4. 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).
5. Patient has already been selected for endovascular treatment of the target aneurysm with the Pipeline™ Shield Device as the appropriate treatment per the Pipeline™ Shield Device Instructions For Use (IFU).

Exclusion Criteria:

1. Patient who is, or is expected to be, inaccessible for follow-up.
2. Participation is excluded by local law.
3. 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).
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 contraindicated for the device or procedure per the Pipeline™ Shield Device IFU.
6. The Investigator determined that the health of the patient may be compromised by the patient's enrollment.
7. 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.

Primary outcomes:
measure: Incidence of the composite outcome (Occlusion of the target aneurysm, Significant parent artery stenosis, Retreatment of the target aneurysm) at 1 year post-procedure.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Jacksonville
country: United States
facility: Baptist Medical Center Jacksonville
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Evanston
country: United States
facility: Endeavor Health - Evanston Hospital
state: Illinois
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Saint Louis
country: United States
facility: Washington University in Saint Louis
state: Missouri
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma (OU) University Medical Center
state: Oklahoma
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
Study officials:
affiliation: Medtronic
name: Harsh Sancheti
role: STUDY_DIRECTOR
References: