Back to resultsEvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE) (ELEVATE)
Primary Purpose
Intracranial Aneurysm, Ruptured Aneurysm
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pipeline™ Flex Embolization Device with Shield Technology™
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Aneurysm focused on measuring wide neck, intradural aneurysm
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Subject is at high risk of noncompliance per treating physician due to reasons including but not limited to a history of substance abuse.
- Subject is unable to complete scheduled follow-up assessments due to comorbidities, geographical limitations, or a life expectancy of less than 24 months.
- Subject is pregnant, or breastfeeding at the time of admission or plans to become pregnant during their participation in the study.
- Subject is participating in another clinical study at the time of enrollment.
- Presumed septic embolus, or suspicion of microbial superinfection.
- Subject with a known COVID-19 viral infection, confirmed by testing.
- Subject in whom a pre-existing stent is in place in the parent artery at target aneurysm location.
Sites / Locations
- University of Colorado HospitalRecruiting
- Yale New Haven HospitalRecruiting
- Baptist Medical Center JacksonvilleRecruiting
- Wellstar Kennestone HospitalRecruiting
- Rush University Medical CenterRecruiting
- University of Kentucky Albert B Chandler HospitalRecruiting
- Washington University in Saint LouisRecruiting
- Stony Brook University HospitalRecruiting
- Geisinger Medical CenterRecruiting
- Thomas Jefferson University HospitalRecruiting
- Semmes Murphey ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pipeline™ Flex Embolization Device with Shield Technology™
Arm Description
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.
Outcomes
Primary Outcome Measures
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%.
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.
Secondary Outcome Measures
Pipeline™ Flex Device Deployment Success Rate
Incidence of rebleed of target aneurysm
Incidence of neurological hemorrhagic serious adverse events
Incidence of ipsilateral major stroke or neurological death post-procedure after 30 days
Incidence of any ipsilateral stroke post-procedure after 30 days
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
Incidence of parent artery thrombosis
Incidence of in-construct stenosis > 50%
Incidence of retreatment
Incidence of peri-/post-procedural serious adverse events related to the device, procedure or antiplatelet therapy
Incidence of neurological death or disabling stroke
Incidence of complete angiographic occlusion without significant stenosis (≤ 50%), and no rebleeding or retreatment of the target aneurysm
Full Information
NCT ID
NCT04391803
First Posted
April 21, 2020
Last Updated
October 4, 2023
Sponsor
Medtronic Neurovascular Clinical Affairs
1. Study Identification
Unique Protocol Identification Number
NCT04391803
Brief Title
EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)
Acronym
ELEVATE
Official Title
EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Neurovascular Clinical Affairs
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm, Ruptured Aneurysm
Keywords
wide neck, intradural aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pipeline™ Flex Embolization Device with Shield Technology™
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Pipeline™ Flex Embolization Device with Shield Technology™
Other Intervention Name(s)
Pipeline™ Shield Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of complete angiographic occlusion without significant stenosis, and no rebleeding or retreatment of the target aneurysm
Description
Occlusion is measured by the Raymond Roy Scale. Significant stenosis is classified as ≤ 50%.
Time Frame
at 180-day
Title
Incidence of neurological death or disabling stroke post-procedure.
Description
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.
Time Frame
at 180-day
Secondary Outcome Measure Information:
Title
Pipeline™ Flex Device Deployment Success Rate
Time Frame
Day 0 During Procedure
Title
Incidence of rebleed of target aneurysm
Time Frame
through 180-day and 365-day post procedure
Title
Incidence of neurological hemorrhagic serious adverse events
Time Frame
through 180-day and 365-day post procedure
Title
Incidence of ipsilateral major stroke or neurological death post-procedure after 30 days
Time Frame
through 180-day and 365-day post procedure
Title
Incidence of any ipsilateral stroke post-procedure after 30 days
Time Frame
through 180-day and 365-day post procedure
Title
Good clinical outcome (modified Rankin Scale (mRS) 0-2)
Description
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
Time Frame
at 30-day, 180-day and 365-day post procedure
Title
Incidence of parent artery thrombosis
Time Frame
through 365-day post procedure
Title
Incidence of in-construct stenosis > 50%
Time Frame
through 365-day post procedure
Title
Incidence of retreatment
Time Frame
through 180-day and 365-day post procedure
Title
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
Title
Incidence of neurological death or disabling stroke
Time Frame
through 365-day post procedure
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Subject is at high risk of noncompliance per treating physician due to reasons including but not limited to a history of substance abuse.
Subject is unable to complete scheduled follow-up assessments due to comorbidities, geographical limitations, or a life expectancy of less than 24 months.
Subject is pregnant, or breastfeeding at the time of admission or plans to become pregnant during their participation in the study.
Subject is participating in another clinical study at the time of enrollment.
Presumed septic embolus, or suspicion of microbial superinfection.
Subject with a known COVID-19 viral infection, confirmed by testing.
Subject in whom a pre-existing stent is in place in the parent artery at target aneurysm location.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medtronic Neurovascular Clinical Affairs
Phone
949-837-3700
Email
rs.elevate@medtronic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Arthur, MD
Organizational Affiliation
Semmes Murphey Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Fiorella, MD
Organizational Affiliation
Stony Brook University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Case, MD
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Matouk, MD
Facility Name
Baptist Medical Center Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo Hanel, MD
Facility Name
Wellstar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Khaldi, MD
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R. Webster Crowley, MD
Facility Name
University of Kentucky Albert B Chandler Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Fraser, MD
Facility Name
Washington University in Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akash Kansagra, MD
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Fiorella, MD
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clemens Schirmer, MD
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal Jabbour, MD
Facility Name
Semmes Murphey Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucas Elijovich, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be available.
Learn more about this trial
EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)
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