Jacksonville, FLNCT07225075Now EnrollingIRB Ready

Intracranial Aneurysm Clinical Trial in Jacksonville, FL

Access cutting-edge intracranial aneurysm treatment through this clinical trial at a research site in Jacksonville. Study-provided care at no cost to qualified participants.

Sponsored by Balt USA

Quick Self-Assessment

See if you qualify for this Jacksonville location

Preparing your pre-screening questions…

Expert Care in Jacksonville

Access intracranial aneurysm specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related intracranial aneurysm treatment provided free

Apply for This Jacksonville Location

Check if you qualify for this intracranial aneurysm clinical trial in Jacksonville, FL

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Jacksonville

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Jacksonville site if eligible
  4. 4Begin participation

About This Intracranial Aneurysm Study in Jacksonville

The PIONEER Study is a pivotal, multi-center, prospective, single-arm study designed to evaluate the safety and efficacy of the Silk Vista Baby (SVB) Flow Diverter for the treatment of unruptured aneurysms.

Sponsor: Balt USA

Who Can Participate

Inclusion Criteria

Age 22 to ≤ 80 years old
Participant has a single target unruptured intracranial aneurysm (IA) originating from a parent vessel of 1.5 mm to 3.4mm in diameter located at or distal to the ICA terminus or in SVB-amenable anterior or posterior anatomy
Participant has a target saccular or fusiform IA with an aneurysm neck ≥ 4mm or a dome to neck ratio \<2
Participant has a target IA that is ≤ 12 mm
Participant meets one or more risk factors for IA rupture, such as age (≤70); hypertension; cigarette smoking; use of sympathomimetic drugs; Japanese or Finnish ancestry; history of prior aneurysmal subarachnoid hemorrhage (aSAH); familial intracranial aneurysms or SAH; clinical or radiological mass effect; reduced quality of life due to fear of rupture; IA size, location, and morphology (yielding 1 point or greater score per UIATS scale); documented growth of IA on serial imaging; presence of multiple IAs; and presence of concurrent pathology
Participant has pre-procedure (obtained up to 14 days prior to the procedure day) PRU value between 60-200
Participant or a legally authorized representative (LAR) provides written informed consent using the IRB/REB-approved consent form and agrees to comply with protocol follow-up and requirements

Exclusion Criteria

Target aneurysm is unsuitable for flow diverter treatment
Subject requires more than one flow diverter for target aneurysm treatment
Has vessel characteristics, such as severe tortuosity, stenosis, atherosclerotic disease, or morphology that would preclude safe endovascular access to the target aneurysm necessary for treatment with the study device
Received previous treatment of the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
Has a medical contraindication to study or procedure-related antiplatelet/anticoagulation medications (e.g., aspirin, clopidogrel/Plavix, ticagrelor, Prasugrel, Gp IIb/IIIa inhibitors, heparin, etc.), local or general anesthesia, or life-threatening allergy to contrast dye
Has a known severe allergy to nickel, titanium or platinum
Modified Rankin Score (mRS) assessment is ≥ 3 at screening or pre-procedure mRS could not be assessed
The health of the participant or the validity of the study outcomes (e.g., high risk of neurologic events, worsening of clinical condition in the last 30 days) may be compromised by the participant's enrollment
Subarachnoid hemorrhage occurred within 30 days prior to enrollment
Intracranial parenchymal hemorrhage occurred within 60 days prior to enrollment
Major surgery (including previous intracranial implant) occurred within previous 30 days or is planned in the next 120 days after treatment date
Has more than one IA that requires treatment within 120 days of treatment date
Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 12 weeks prior to treatment date
Requires adjunctive coiling during SVB procedure
Chronic anticoagulation therapy is ongoing or known coagulopathy exists
Has other known serious concurrent medical conditions such as active bacterial infection, heart disease (including atrial fibrillation, pacemaker, recent myocardial infarction \[\< 12 weeks\], symptomatic congestive heart failure, or carotid stenosis), kidney failure (e.g., \>2.0mg/dl serum creatinine) or any other non-neurological disease-related acute life threatening illness to be treated in this trial, pulmonary disease, uncontrolled diabetes, progressive neurologic disorders, cancer requiring active treatment (e.g., chemotherapy, etc.) or on palliative care, vasculitis, high risk of ischemic stroke or recent stroke (within 30 days)
Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm)
Unable to complete study follow-up due to dementia or psychiatric disorder, substance abuse, or history of noncompliance with medical advice
Women who are pregnant or nursing at the time of enrollment or women who wish to become pregnant during the length of study participation
Presence of intracranial mass (tumor, except meningioma that doesn't require surgery for 1 year) or non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
Participation in any other investigational study which can influence collection of valid data under this study

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 Jacksonville?

Yes, this clinical trial (NCT07225075) has an active research site in Jacksonville, FL 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.

Intracranial Aneurysm Treatment Options in Jacksonville, FL

If you're searching for intracranial aneurysm treatment options in Jacksonville, FL, this clinical trial (NCT07225075) 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 Jacksonville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced intracranial 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 intracranial aneurysm clinical trials near you to find additional studies recruiting in your area.

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