INSPIRE Pipeline™ Shield Post Approval Study

Intracranial Aneurysm Clinical Trial

Official title:

Neurovascular Product Surveillance Registry (INSPIRE) Pipeline™ Flex Embolization Device With Shield Technology™ Post Approval Study (PAS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05071963
• Other study ID #: MDT16056
• Status: Recruiting
• Start date: December 20, 2021
• Est. completion date: March 2027

Study information

• Verified date: May 2024
• Source: Medtronic Neurovascular Clinical Affairs
• Contact: Medtronic Neurovascular Clinical Affairs
• Phone: 949-837-3700
• Email: rs.shieldpostapproval[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 203
• Est. completion date: March 2027
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Treatment of Intracranial Aneurysms
Embolization of aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Baylor Scott & White Research Institute	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Prisma Health	Greenville	South Carolina
United States	Baptist Medical Center Jacksonville	Jacksonville	Florida
United States	Norton Healthcare	Louisville	Kentucky
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	NYU Langone Medical Center	New York	New York
United States	Oklahoma (OU) University Medical Center	Oklahoma City	Oklahoma
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington University in Saint Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Neurovascular Clinical Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of the composite outcome (Occlusion of the target aneurysm, Significant parent artery stenosis, Retreatment of the target aneurysm) at 1 year post-procedure.	Incidence at 1-year post-procedure of complete occlusion of the target aneurysm, significant parent artery stenosis = 50%, and no retreatment of the target aneurysm.	1 year