Status:
SUSPENDED
EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)
Lead Sponsor:
Medtronic Neurovascular Clinical Affairs
Conditions:
Intracranial Aneurysm
Ruptured Aneurysm
Eligibility:
All Genders
22-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04391803
Start Date
May 6 2022
End Date
October 1 2025
Last Update
June 6 2025
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado Hospital
Aurora, Colorado, United States, 80045
2
Swedish Medical Center
Englewood, Colorado, United States, 80113
3
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
4
Baptist Medical Center Jacksonville
Jacksonville, Florida, United States, 32207