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

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ClinicalTrials.gov Identifier: NCT04391803
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : December 9, 2022
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Ruptured Aneurysm Device: Pipeline™ Flex Embolization Device with Shield Technology™ Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)
Actual Study Start Date : May 6, 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Pipeline™ Shield Device


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of complete angiographic occlusion without significant stenosis, and no rebleeding or retreatment of the target aneurysm [ Time Frame: at 180-day ]
    Occlusion is measured by the Raymond Roy Scale. Significant stenosis is classified as ≤ 50%.

  2. Incidence of neurological death or disabling stroke post-procedure. [ Time Frame: at 180-day ]
    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.


Secondary Outcome Measures :
  1. Pipeline™ Flex Device Deployment Success Rate [ Time Frame: Day 0 During Procedure ]
  2. Incidence of rebleed of target aneurysm [ Time Frame: through 180-day and 365-day post procedure ]
  3. Incidence of neurological hemorrhagic serious adverse events [ Time Frame: through 180-day and 365-day post procedure ]
  4. Incidence of ipsilateral major stroke or neurological death post-procedure after 30 days [ Time Frame: through 180-day and 365-day post procedure ]
  5. Incidence of any ipsilateral stroke post-procedure after 30 days [ Time Frame: through 180-day and 365-day post procedure ]
  6. Good clinical outcome (modified Rankin Scale (mRS) 0-2) [ Time Frame: at 30-day, 180-day and 365-day post procedure ]

    Scale for measuring general neurologic function:

    0- No symptoms at all

    1. No significant disability despite symptoms; able to carry out all usual duties and activities
    2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    3. Moderate disability; requiring some help, but able to walk without assistance
    4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention
    6. Dead

  7. Incidence of parent artery thrombosis [ Time Frame: through 365-day post procedure ]
  8. Incidence of in-construct stenosis > 50% [ Time Frame: through 365-day post procedure ]
  9. Incidence of retreatment [ Time Frame: through 180-day and 365-day post procedure ]
  10. Incidence of peri-/post-procedural serious adverse events related to the device, procedure or antiplatelet therapy [ Time Frame: through 180-day and 365-day post procedure ]
  11. Incidence of neurological death or disabling stroke [ Time Frame: through 365-day post procedure ]
  12. Incidence of complete angiographic occlusion without significant stenosis (≤ 50%), and no rebleeding or retreatment of the target aneurysm [ Time Frame: through 365-day post procedure ]

Eligibility Criteria
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Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391803


Contacts
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Contact: Medtronic Neurovascular Clinical Affairs 949-837-3700 rs.elevate@medtronic.com

Locations
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United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: David Case, MD         
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Charles Matouk, MD         
United States, Florida
Baptist Medical Center Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Ricardo Hanel, MD         
United States, Georgia
Wellstar Kennestone Hospital Recruiting
Marietta, Georgia, United States, 30060
Contact: Ahmad Khaldi, MD         
United States, Kentucky
University of Kentucky Albert B Chandler Hospital Recruiting
Lexington, Kentucky, United States, 40506
Contact: Justin Fraser, MD         
United States, Missouri
Washington University in Saint Louis Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Akash Kansagra, MD         
United States, New York
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
Contact: David Fiorella, MD         
United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Clemens Schirmer, MD         
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Pascal Jabbour, MD         
United States, Tennessee
Semmes Murphey Clinic Recruiting
Memphis, Tennessee, United States, 38120
Contact: Lucas Elijovich, MD         
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
Investigators
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Principal Investigator: Adam Arthur, MD Semmes Murphey Clinic
Principal Investigator: David Fiorella, MD Stony Brook University Hospital
More Information
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Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT04391803    
Other Study ID Numbers: MDT19025TRACER
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: December 9, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Medtronic Neurovascular Clinical Affairs:
wide neck
intradural aneurysm
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Aneurysm, Ruptured
Vascular Diseases
Cardiovascular Diseases
 Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases