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EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)

NCT04391803•Medtronic Neurovascular Clinical Affairs

Summary

The purpose of the study is to assess the safety and effectiveness of the Pipeline™ Flex Embolization Device with Shield Technology™ in the treatment with acutely ruptured intracranial aneurysms.

Detailed Description

The ELEVATE study is a prospective, multi-center, single-arm trial of the Pipeline™ Shield Device for the treatment of adults with acutely ruptured intracranial aneurysms. The primary objective of the ELEVATE study is to assess the safety and effectiveness of treatment with the Pipeline™ Shield Device of acutely ruptured intracranial aneurysms that are not amenable for clipping and coiling.

Eligibility

Age

22 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject has a previously untreated, wide neck, side-wall, intradural aneurysm that is deemed unfavorable for both surgical clipping and endovascular coiling, as confirmed on DSA.
•2. Subject has a ruptured intracranial aneurysm with vessel diameter suitable for treatment with the study device.
•3. Subject is ≥ 22 and ≤ 80 years of age.
•4. Subject has an acutely ruptured aneurysm with Hunt and Hess Scale 1, 2 or 3.
•5. Subject or subject's Legally Authorized Representative (LAR) has provided written informed consent.

Exclusion Criteria

•1. Subject's vessel characteristics preclude safe endovascular access to the aneurysm to treat with the Pipeline™ Shield Device.
•2. Subject has aneurysm vessel characteristics that would preclude the device from fully conforming to the parent vessel to reduce any risk of embolic complications, retreatment, or device movement.
•3. Subject has true bifurcation or aneurysms with vessels that cannot be separated from the fundus with placement of the study device.
•4. Subject with intraparenchymal hemorrhage.
•5. Subject is unable to undergo nasogastric/orogastric tube placement prior to device placement.
•6. Subject has a pre-morbid mRS \>2.
•7. Subject requires treatment of another aneurysm (with another treatment modality) within the affected territory of the target aneurysm.
•8. Subject has a target ruptured aneurysm that is thought to be mycotic, including those caused by left atrial myxoma, or subject has an active systemic bacterial infection.
•9. Subject with a requirement for continuous anti-coagulation.
•10. Subject has a malignant brain tumor or vascular malformation (e.g. arteriovenous malformation).
+12 more criteria

Locations (7)

Yale New Haven Hospital

New Haven, Connecticut, United States

Wellstar Kennestone Hospital

Marietta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Kentucky Albert B Chandler Hospital

Lexington, Kentucky, United States

Stony Brook University Hospital

Stony Brook, New York, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Semmes Murphey Clinic

Memphis, Tennessee, United States

Key Dates

Start Date

May 6, 2022

Primary Completion Date

October 20, 2025

Completion Date

October 20, 2025

Last Updated

January 27, 2026

Enrollment

ACTUAL participants

Conditions

Intracranial AneurysmRuptured Aneurysm

Interventions

Pipeline™ Flex Embolization Device with Shield Technology™

DEVICE

Targeting Real World Usage In Stroke Treatment

NCT07474935

Saccular and Fusiform AneurysmsPseudoaneurysm+7 more

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RECRUITING

Product Surveillance Registry

NCT01524276

Cardiac Rhythm DisordersUrological Disorders+14 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)

Inclusion Criteria

Exclusion Criteria

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