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

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.

Study Overview

• Status: Recruiting
• Conditions: Intracranial Aneurysm; Ruptured Aneurysm
• Intervention / Treatment: Device: Pipeline™ Flex Embolization Device with Shield Technology™

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Medtronic Neurovascular Clinical Affairs; Phone Number: 949-837-3700; Email: rs.elevate@medtronic.com

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital
      • Contact: David Case, MD
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale New Haven Hospital
      • Contact: Charles Matouk, MD
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Recruiting
      • Baptist Medical Center Jacksonville
      • Contact: Ricardo Hanel, MD
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Recruiting
      • Wellstar Kennestone Hospital
      • Contact: Ahmad Khaldi, MD
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Contact: R. Webster Crowley, MD
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Recruiting
      • University of Kentucky Albert B Chandler Hospital
      • Contact: Justin Fraser, MD
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Recruiting
      • Washington University in Saint Louis
      • Contact: Akash Kansagra, MD
  • New York
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University Hospital
      • Contact: David Fiorella, MD
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Recruiting
      • Geisinger Medical Center
      • Contact: Clemens Schirmer, MD
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital
      • Contact: Pascal Jabbour, MD
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Recruiting
      • Semmes Murphey Clinic
      • Contact: Lucas Elijovich, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).
11. Subject's target ruptured aneurysm has not been determined by the treating physician to be the source of SAH.
12. Subject with known allergy to platinum or cobalt chromium alloy (including the major elements platinum, cobalt, chromium, nickel or molybdenum).
13. Subject has a known hypersensitivity to ticagrelor or aspirin.
14. Subject is unable to undergo DSA or DSA is determined unsuitable by the treating physician.
15. Subject has a serious or life-threatening comorbidity that could confound study results.
16. Subject is at high risk of noncompliance per treating physician due to reasons including but not limited to a history of substance abuse.
17. Subject is unable to complete scheduled follow-up assessments due to comorbidities, geographical limitations, or a life expectancy of less than 24 months.
18. Subject is pregnant, or breastfeeding at the time of admission or plans to become pregnant during their participation in the study.
19. Subject is participating in another clinical study at the time of enrollment.
20. Presumed septic embolus, or suspicion of microbial superinfection.
21. Subject with a known COVID-19 viral infection, confirmed by testing.
22. Subject in whom a pre-existing stent is in place in the parent artery at target aneurysm location.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pipeline™ Flex Embolization Device with Shield Technology™; 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™; 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.; Other Names: Pipeline™ Shield Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 180-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 180-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Good clinical outcome (modified Rankin Scale (mRS) 0-2)	Scale for measuring general neurologic function: 0- No symptoms at all; No significant disability despite symptoms; able to carry out all usual duties and activities; Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; Moderate disability; requiring some help, but able to walk without assistance; Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; Severe disability; bedridden, incontinent and requiring constant nursing care and attention; Dead	at 30-day, 180-day and 365-day post procedure
Incidence of parent artery thrombosis		through 365-day post procedure
Incidence of in-construct stenosis > 50%		through 365-day post procedure
Incidence of retreatment		through 180-day and 365-day post procedure
Incidence of peri-/post-procedural serious adverse events related to the device, procedure or antiplatelet therapy		through 180-day and 365-day post procedure
Incidence of neurological death or disabling stroke		through 365-day post procedure
Incidence of complete angiographic occlusion without significant stenosis (≤ 50%), and no rebleeding or retreatment of the target aneurysm		through 365-day post procedure

Collaborators and Investigators

• Sponsor: Medtronic Neurovascular Clinical Affairs
• Investigators: Principal Investigator: Adam Arthur, MD, Semmes Murphey Clinic; Principal Investigator: David Fiorella, MD, Stony Brook University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2022
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: wide neck; intradural aneurysm
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm; Aneurysm, Ruptured
• Other Study ID Numbers: MDT19025TRACER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes