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Endovascular Treatment for Brain Aneurysm (ELEVATE Trial)
ELEVATE Trial Summary
This trial will test the safety and effectiveness of the Pipeline Flex Embolization Device with Shield Technology for treating people with aneurysms that have recently ruptured.
ELEVATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowELEVATE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ELEVATE Trial Design
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Who is running the clinical trial?
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- I need to be on blood thinners all the time.I have a malignant brain tumor or a vascular malformation.You have a stent in the main artery near the aneurysm.My aneurysm has not been treated and is difficult to treat with surgery or coiling.I have a ruptured aneurysm suspected to be caused by infection or I have an active bacterial infection.My health was good before my current illness, with no significant disabilities.I might have an infection in my blood or a secondary infection.I have a recently burst aneurysm and my condition is mild to moderate.You have a type of blood vessel condition that can't be treated with the study device.My blood vessels are not suitable for treatment with the Pipeline™ Shield Device.I need treatment for another aneurysm near the one being studied.You are allergic to ticagrelor or aspirin.My doctor does not believe my aneurysm caused my bleeding in the brain.I have tested positive for COVID-19.I cannot have or was deemed unsuitable for a specific artery imaging test.I have a serious health condition that could affect the study's outcome.I cannot have a tube placed in my nose or mouth before the device is placed.You have an aneurysm that would make it difficult for the device to fit properly and could increase the risk of complications.I am between 22 and 80 years old.I have a burst blood vessel in my brain that fits the treatment size requirements.I have had bleeding within the brain.You are allergic to platinum or cobalt chromium alloy.
Frequently Asked Questions
What is the upper limit of volunteers taking part in this medical study?
"This clinical trial necessitates 200 participants that meet the established inclusion criteria. WellStar Kennestone Hospital in Marietta, Georgia and University of Colorado Hospital in Aurora, Colorado are two sites among many offering this medical study."
Is this research initiative still recruiting participants?
"According to clinicaltrials.gov, this research initiative is in need of participants. The trial was initially launched on May 6th 2022 and most recently modified on November 1st 2022."
Who are the ideal candidates to partake in this clinical experiment?
"This research is in search of 200 patients with a ruptured aneurysm aged 22 to 80. Applicants must meet the following requirements: Subject has not been treated for a wide neck, sidewall, intra-dural aneurysm deemed unsuitable for either surgical clipping or endovascular coiling as confirmed by DSA., Subject's intracranial aneurysm diameter is appropriate for treatment with the study device., Age range between 22 and 80 years old., The individual has experienced recently ruptured aneurysm according to Hunt and Hess Scale 1, 2 or 3."
How many research sites are engaging in this experiment?
"Participants of this research can be enrolled at a number of sites, such as WellStar Kennestone Hospital in Marietta, Georgia; University of Colorado Hospital in Aurora, Colorado; and Yale New Haven Hospital in New Haven, Connecticut."
Does this clinical trial accept senior citizens as participants?
"This clinical trial necessitates that applicants be between the ages of 22 and 80. Additionally, there are 7 trials specifically tailored to younger patients under 18 years old, as well as 151 studies open for participants aged 65 or older."
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