Clinical trial NCT04391803: EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (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
Overall status: SUSPENDED
Phase: NA
Conditions: Intracranial Aneurysm
Ruptured Aneurysm
Keywords: wide neck
intradural aneurysm
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2020-05-18
Enrollment: 200
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of complete angiographic occlusion without significant stenosis, and no rebleeding or retreatment of the target aneurysm
timeFrame: at 180-day
measure: Incidence of neurological death or disabling stroke post-procedure.
timeFrame: at 180-day
Secondary outcomes:
measure: Pipeline™ Flex Device Deployment Success Rate
timeFrame: Day 0 During Procedure
measure: Incidence of rebleed of target aneurysm
timeFrame: through 180-day and 365-day post procedure
measure: Incidence of neurological hemorrhagic serious adverse events
timeFrame: through 180-day and 365-day post procedure
measure: Incidence of ipsilateral major stroke or neurological death post-procedure after 30 days
timeFrame: through 180-day and 365-day post procedure
measure: Incidence of any ipsilateral stroke post-procedure after 30 days
timeFrame: through 180-day and 365-day post procedure
measure: Good clinical outcome (modified Rankin Scale (mRS) 0-2)
timeFrame: at 30-day, 180-day and 365-day post procedure
measure: Incidence of parent artery thrombosis
timeFrame: through 365-day post procedure
measure: Incidence of in-construct stenosis > 50%
timeFrame: through 365-day post procedure
measure: Incidence of retreatment
timeFrame: through 180-day and 365-day post procedure
measure: Incidence of peri-/post-procedural serious adverse events related to the device, procedure or antiplatelet therapy
timeFrame: through 180-day and 365-day post procedure
measure: Incidence of neurological death or disabling stroke
timeFrame: through 365-day post procedure
measure: Incidence of complete angiographic occlusion without significant stenosis (≤ 50%), and no rebleeding or retreatment of the target aneurysm
timeFrame: through 365-day post procedure
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Englewood
country: United States
facility: Swedish Medical Center
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Jacksonville
country: United States
facility: Baptist Medical Center Jacksonville
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Marietta
country: United States
facility: Wellstar Kennestone Hospital
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Albert B Chandler Hospital
state: Kentucky
city: Saint Louis
country: United States
facility: Washington University in Saint Louis
state: Missouri
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Semmes Murphey Clinic
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Semmes Murphey Clinic
name: Adam Arthur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stony Brook University Hospital
name: David Fiorella, MD
role: PRINCIPAL_INVESTIGATOR
References: