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

Last updated: June 5, 2025
Sponsor: Medtronic Neurovascular Clinical Affairs
Overall Status: Suspended

Phase

N/A

Condition

Aneurysm

Treatment

Pipeline™ Flex Embolization Device with Shield Technology™

Clinical Study ID

NCT04391803
MDT19025TRACER
  • Ages 22-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject has a previously untreated, wide neck, side-wall, intradural aneurysm thatis deemed unfavorable for both surgical clipping and endovascular coiling, asconfirmed on DSA.

  2. Subject has a ruptured intracranial aneurysm with vessel diameter suitable fortreatment 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 writteninformed consent.

Exclusion

Exclusion Criteria:

  1. Subject's vessel characteristics preclude safe endovascular access to the aneurysmto treat with the Pipeline™ Shield Device.

  2. Subject has aneurysm vessel characteristics that would preclude the device fromfully 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 fromthe fundus with placement of the study device.

  4. Subject with intraparenchymal hemorrhage.

  5. Subject is unable to undergo nasogastric/orogastric tube placement prior to deviceplacement.

  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, includingthose caused by left atrial myxoma, or subject has an active systemic bacterialinfection.

  9. Subject with a requirement for continuous anti-coagulation.

  10. Subject has a malignant brain tumor or vascular malformation (e.g. arteriovenousmalformation).

  11. Subject's target ruptured aneurysm has not been determined by the treating physicianto be the source of SAH.

  12. Subject with known allergy to platinum or cobalt chromium alloy (including the majorelements 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 treatingphysician.

  15. Subject has a serious or life-threatening comorbidity that could confound studyresults.

  16. Subject is at high risk of noncompliance per treating physician due to reasonsincluding 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 becomepregnant 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 targetaneurysm location.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Pipeline™ Flex Embolization Device with Shield Technology™
Phase:
Study Start date:
May 06, 2022
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • University of Colorado Hospital

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Swedish Medical Center

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Baptist Medical Center Jacksonville

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Jackson Memorial Hospital

    Miami, Florida 33136
    United States

    Site Not Available

  • Wellstar Kennestone Hospital

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Kentucky Albert B Chandler Hospital

    Lexington, Kentucky 40506
    United States

    Site Not Available

  • Washington University in Saint Louis

    Saint Louis, Missouri 63130
    United States

    Site Not Available

  • Stony Brook University Hospital

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Medical University of South Carolina

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Semmes Murphey Clinic

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

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