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

NCT04391803 | Terminated DMC FDA Device

• 1 other identifier: MDT19025TRACER
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Intracranial Aneurysm; Ruptured Aneurysm

Keywords

wide neck; intradural aneurysm

Outcome Measures

Primary Outcomes (2)

• Incidence of complete angiographic occlusion without significant stenosis, and no rebleeding or retreatment of the target aneurysm

  Occlusion is measured by the Raymond Roy Scale. Significant stenosis is classified as ≤ 50%.

  at 365-day

• Incidence of neurological death or disabling stroke post-procedure.

  Disabling stroke is defined as any post-procedural ischemic or hemorrhagic event that results in poor functional outcome (i.e. mRS ≥ 3 points) assessed at 90 days post stroke event.

  at 365-day

Secondary Outcomes (12)

• Pipeline™ Flex Device Deployment Success Rate

  Day 0 During Procedure

• Incidence of rebleed of target aneurysm

  through 180-day and 365-day post procedure

• Incidence of neurological hemorrhagic serious adverse events

  through 180-day and 365-day post procedure

• Incidence of ipsilateral major stroke or neurological death post-procedure after 30 days

  through 180-day and 365-day post procedure

• Incidence of any ipsilateral stroke post-procedure after 30 days

  through 180-day and 365-day post procedure

Study Arms (1)

Pipeline™ Flex Embolization Device with Shield Technology™

EXPERIMENTAL

This is a prospective, single-arm study in which subjects have consented and deployment of the Pipeline™ Flex Embolization Device with Shield Technology™ is attempted.

Device: Pipeline™ Flex Embolization Device with Shield Technology™

Interventions

Pipeline™ Flex Embolization Device with Shield Technology™ DEVICE

The Pipeline™ Flex Embolization Device with Shield Technology™ is intended for endovascular treatment of adults with intracranial acutely ruptured aneurysms not amenable to clipping and coiling.

Also known as: Pipeline™ Shield Device

Pipeline™ Flex Embolization Device with Shield Technology™

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subject has a ruptured intracranial aneurysm with vessel diameter suitable for treatment with the study device.
• Subject is ≥ 22 and ≤ 80 years of age.
• Subject has an acutely ruptured aneurysm with Hunt and Hess Scale 1, 2 or 3.
• Subject or subject's Legally Authorized Representative (LAR) has provided written informed consent.

You may not qualify if:

• Subject's vessel characteristics preclude safe endovascular access to the aneurysm to treat with the Pipeline™ Shield Device.
• 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.
• Subject has true bifurcation or aneurysms with vessels that cannot be separated from the fundus with placement of the study device.
• Subject with intraparenchymal hemorrhage.
• Subject is unable to undergo nasogastric/orogastric tube placement prior to device placement.
• Subject has a pre-morbid mRS \>2.
• Subject requires treatment of another aneurysm (with another treatment modality) within the affected territory of the target aneurysm.
• 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.
• Subject with a requirement for continuous anti-coagulation.
• Subject has a malignant brain tumor or vascular malformation (e.g. arteriovenous malformation).
• Subject's target ruptured aneurysm has not been determined by the treating physician to be the source of SAH.
• Subject with known allergy to platinum or cobalt chromium alloy (including the major elements platinum, cobalt, chromium, nickel or molybdenum).
• Subject has a known hypersensitivity to ticagrelor or aspirin.
• Subject is unable to undergo DSA or DSA is determined unsuitable by the treating physician.
• Subject has a serious or life-threatening comorbidity that could confound study results.

Sponsors & Collaborators

• Medtronic Neurovascular Clinical Affairs: lead

Study Sites (7)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Kentucky Albert B Chandler Hospital

Lexington, Kentucky, 40506, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Semmes Murphey Clinic

Memphis, Tennessee, 38120, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm, Ruptured

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• David Fiorella, MD

  Stony Brook University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: May 18, 2020
• Study Start: May 6, 2022
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)