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Tests treatment safety and results for Aneurysm
Official title Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)
ClinicalTrials.gov ID: NCT06872684
What this study is testing
- What it's testing
- The objective of the Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms with Surpass Elite with GUARDian Flow Diverter (GUARD) trial is to evaluate the safety and efficacy of the Surpass Elite with Guardian Flow Diverter System (FDS) in the treatment of unruptured, wide-neck saccular or fusiform, intracranial aneurysms (IAs) located on the internal carotid artery (ICA) or its branches.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age is ≥18 and ≤80 years at the time of consent
- Has a single unruptured target intracranial aneurysm (IA) of any size with the following characteristics:
- Is located on the internal carotid artery or its branches
- Has a wide neck (wide neck typically defined as neck width ≥ 4 millimeter (mm), or dome to neck ratio ≤ 2.0) or no discernible neck
- Aneurysm is either saccular or fusiform in nature
You likely can't join if
- Has an extradural target aneurysm
- Has a target aneurysm in the posterior circulation
- Perforator or branch vessel, inclusive of the posterior communicating artery, arises from the target aneurysm body or neck (branches or arteries must...
- Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation
- Has vessel characteristics, such as severe tortuosity (cavernous Internal Carotid Artery (cICA) Type IV1), stenosis (\>70%), or morphology that would...
- Received previous treatment for the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
See the full eligibility criteria
Who can join
- Age is ≥18 and ≤80 years at the time of consent
- Has a single unruptured target intracranial aneurysm (IA) of any size with the following characteristics:
- Is located on the internal carotid artery or its branches
- Has a wide neck (wide neck typically defined as neck width ≥ 4 millimeter (mm), or dome to neck ratio ≤ 2.0) or no discernible neck
- Aneurysm is either saccular or fusiform in nature
- Has a parent vessel diameter ≥ 3.0 mm to ≤ 6.0 mm at the largest diameter
- There is documented risk-benefit of endovascular treatment that outweighs the risks of intracranial aneurysm rupture during the subject's expected lifetime if left untreated.
What rules you out
- Has an extradural target aneurysm
- Has a target aneurysm in the posterior circulation
- Perforator or branch vessel, inclusive of the posterior communicating artery, arises from the target aneurysm body or neck (branches or arteries must arise or connect from the parent vessel separate from the aneurysm or...
- Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation
- Has vessel characteristics, such as severe tortuosity (cavernous Internal Carotid Artery (cICA) Type IV1), stenosis (\>70%), or morphology that would preclude safe endovascular access or proper deployment of the trial...
- Received previous treatment for the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
- Has a medical contraindication to trial or procedure related antiplatelet medications (aspirin, clopidogrel/Plavix, ticagrelor, and heparin), local or general anesthesia, or life-threatening allergy to contrast dye
- Has a known severe allergy to nickel, chromium cobalt, tungsten, or platinum
- Patients with heparin hypersensitivity, including patients with a previous incident of Heparin-Induced Thrombocytopenia (HIT).
- Modified Rankin Score (mRS) assessment is ≥ 3 at pre-procedure exam
- Presence of unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days prior to the index procedure)
- Subarachnoid hemorrhage occurred within 30 days prior to the index procedure
- Major surgery (including previous intracranial implant) either occurred within 30 days prior to the index procedure date or is planned to occur within 120 days following the index procedure date
- Has more than one intracranial aneurysm (IA) that requires treatment within 12 months after the index procedure
- Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 84 days prior to treatment date
- Chronic anticoagulation therapy is ongoing or known coagulopathy exists
- Has atrial fibrillation with or without pacemaker.
- Has other known serious concurrent medical conditions such as cardiovascular disease (including recent myocardial infarction [\ 2.0 mg/dl serum creatinine), pulmonary disease, uncontrolled diabetes, progressive...
- Has acute life-threatening illness (e.g., acute kidney or heart failure) other than the neurological disease to be treated in this trial
- Evidence of active infection at the time of treatment
- Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm)
- Unable to comply with the trial follow up requirements due to conditions such as dementia or psychiatric problems, active substance abuse, or history of non-compliance with medical advice, as determined by the...
- Pregnant or breast- feeding women or women who wish to become pregnant during the length of trial participation
- Presence of intracranial mass (tumor, except meningioma, abscess, or other infection), non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
- Enrollment in another study involving an investigational product that could confound the outcomes of this trial
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Davis, California, United States
- Palo Alto, California, United States
- Jacksonville, Florida, United States
- Kansas City, Kansas, United States
- Burlington, Massachusetts, United States
- New York, New York, United States
- Stony Brook, New York, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Davis, California, United States; Palo Alto, California, United States; Jacksonville, Florida, United States; Kansas City, Kansas, United States; Burlington, Massachusetts, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.