Is NCT06872684 recruiting in Stony Brook, NY?

Yes, NCT06872684 is currently recruiting participants at its Stony Brook, NY location. This aneurysm clinical trial is actively enrolling qualified participants.

How do I join the aneurysm clinical trial in Stony Brook?

To join this clinical trial in Stony Brook, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Stony Brook clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Aneurysm Clinical Trial in Stony Brook, NY

About This Aneurysm Study in Stony Brook

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.

Sponsor: Stryker Neurovascular

Who Can Participate

Inclusion Criteria

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.

Exclusion Criteria

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 neck to not be excluded from trial)

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 device to the target aneurysm

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 \[\<12 weeks\], symptomatic congestive heart failure, or carotid stenosis), kidney failure (\>2.0 mg/dl serum creatinine), pulmonary disease, uncontrolled diabetes, progressive neurologic disorders, terminal cancer, vasculitis, high risk of ischemic stroke or recent stroke

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 investigator

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Stony Brook?

Yes, this clinical trial (NCT06872684) has an active research site in Stony Brook, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Aneurysm Treatment Options in Stony Brook, NY

If you're searching for aneurysm treatment options in Stony Brook, NY, this clinical trial (NCT06872684) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Stony Brook research site is actively enrolling participants for this clinical trial. You'll receive care from experienced aneurysm specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all aneurysm clinical trials near you to find additional studies recruiting in your area.

Aneurysm Clinical Trial in Stony Brook, NY

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