Tampa, FLNCT02998229Now EnrollingIRB Ready

Intracranial Aneurysm Clinical Trial in Tampa, FL

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

Sponsored by Medtronic Neurovascular Clinical Affairs

Quick Self-Assessment

See if you qualify for this Tampa location

Preparing your pre-screening questionsā€¦

Expert Care in Tampa

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

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

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Why Participate?

  • No-Cost Study Care

  • Local to Tampa

    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 Tampa site if eligible
  4. 4Begin participation

About This Intracranial Aneurysm Study in Tampa

The purpose of this study is to assess the safety and effectiveness of the Artisseā„¢ Intrasaccular Device in the treatment of unruptured and ruptured wide-neck bifurcating intracranial aneurysms.

Sponsor: Medtronic Neurovascular Clinical Affairs

Who Can Participate

Inclusion Criteria

Subject or subject's Legally Authorized Representative (LAR) has provided written informed consent using the Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent Form (ICF). Health Insurance Portability and Accountability Act (HIPAA)/data protection authorization has been provided and signed by the subject or subject's LAR.
Subject is 18-75 years of age at the time of consent.
Subject has a single unruptured or ruptured IA requiring treatment. If the patient has an additional IA, the additional IA must not be deemed to require treatment within 1-year of the index procedure.
The target aneurysm must have the following characteristics:
Saccular morphology
Located at a bifurcation in the anterior or posterior circulation
Aneurysm Width appropriate for treatment with the Artisseā„¢ Intrasaccular Device for device sizingper the Instructions for Use.
Wide-necked, defined as neck size ā‰„ 4 mm and/or a dome-to-neck ratio of ā‰„ 1 and \< 2.
If the target aneurysm was acutely ruptured, subject must be neurologically stable with Hunt and Hess Grade of I or II. Ruptured IA is defined as showing evidence of SAH attributed to the target aneurysm within the last 30-days (using computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP).)
Subject is able to comply with all aspects of the Clinical Investigation Plan (CIP) requirements (e.g., screening, evaluation, treatment, and the post-procedure follow-up schedule).
Subject meets one or more risk factors for IA rupture, such as age, 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, documented growth of IA on serial imaging (or enhanced aneurysm walls on contrast), presence of multiple IAs, and presence of concurrent pathology.
Treating physician has already selected the subject for endovascular treatment of the target aneurysm after considering risk-benefit of clipping vs endovascular treatment
If the subject has an additional IA that was treated previously, the additional IA must have been clinically stable in the past 90 days (i.e. without ongoing adverse events related to the previous treatment).

Exclusion Criteria

During treatment planning, it is determined that subject may need an adjunctive implant device in addition to the Artisseā„¢ Intrasaccular Device. (Subjects who need unplanned adjunctive implant devices are not excluded.)
Subject's target aneurysm was previously treated with other devices/implants (e.g., coils) or parent artery has a stent or other obstruction that could interfere with the correct placement of the Artisseā„¢ Intrasaccular Device.
Subject has a known active systemic bacterial infection.
Subject has anatomy or physiology considered unsuitable (e.g., vessel anomaly or disease) for endovascular treatment with the Artisseā„¢ Intrasaccular Device by the treating physician.
Subject has a mRS score \> 2 (i.e., mRS scores of 3 to 5) prior to procedure (in case of unruptured IA) or prior to rupture (in case of ruptured IA).
Subject has an SAH from a non-target aneurysm or any other intracranial hemorrhage within 90 days.
Subject, of child-bearing potential, is pregnant (confirmed with a positive pregnancy test) or plans to become pregnant during the 1 year follow up period after the index procedure.
Subject is enrolled in another device or drug study in which participation could confound study results.
The treating physician determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, conditions that may increase the chance of stroke) may be compromised by the subject's enrollment.
Subject has a known hypersensitivity, which cannot be medically treated, to any component of the study device, procedural materials, or medications commonly used during the procedure.
Subject is taking anticoagulants (e.g., warfarin) that cannot be discontinued for a minimum of 7 days post-procedure or have a known blood dyscrasia, coagulopathy, or hemoglobinopathy.
Subject has acute or chronic renal failure (unless on dialysis) that would prevent them from undergoing digital subtraction angiography (DSA).
Subject has a life expectancy of less than 5 years due to an illness or condition other than the index IA.

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 Tampa?

Yes, this clinical trial (NCT02998229) has an active research site in Tampa, 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 Tampa, FL

If you're searching for intracranial aneurysm treatment options in Tampa, FL, this clinical trial (NCT02998229) 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 Tampa 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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