Jacksonville, FLNCT05378347Now EnrollingIRB Ready

Abdominal Aortic Aneurysm Clinical Trial in Jacksonville, FL

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

Sponsored by Medtronic Cardiovascular

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Expert Care in Jacksonville

Access abdominal aortic aneurysm specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related abdominal aortic aneurysm treatment provided free

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

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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 Abdominal Aortic Aneurysm Study in Jacksonville

The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint.

Sponsor: Medtronic Cardiovascular

Who Can Participate

Inclusion Criteria

Subject and the treating physician agree that the subject will return for all required follow up visits
Subject or legal representative or consultee, as applicable, has consented for trial participation and signed the Informed Consent approved by the sponsor and by the Ethics Committee/Institutional Review Board
Subject has an aneurysm diameter of ≥ 5 cm (if woman) ≥ 5.5 cm (if man) or as stated otherwise in regional addenda.
Subject's AAA anatomy is appropriate for both Medtronic Endurant II/IIs Stent Graft System and Gore Excluder/Excluder Conformable AAA Endoprosthesis as per assessment of both treating physician and Core Lab in accordance with the overlapping commercially available IFUs per applicable region.

Exclusion Criteria

Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this trial
Subject has an estimated life expectancy of ≤ 3 years as judged by the investigator
Subject has an aneurysm that is:
Suprarenal/pararenal/juxtarenal
Isolated ilio-femoral
Inflammatory
Pseudoaneurysm
Concomitant or prior dissection involving the abdominal aorta or iliac arteries
Symptomatic AAA
Subject has significant thrombus and / or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface. Significant thrombus may be quantified as thrombus ≥ 2 mm in thickness and / or ≥ 25% of the vessel circumference in the intended seal zone of the aortic neck.
Subject requires emergent aneurysm treatment, for example, trauma or rupture
Subject with connective tissue disease that may have caused the aneurysm e.g. Marfan syndrome, Ehlers-Danlos, Loeys-Dietz syndrome
Subject has previously undergone surgical or endovascular treatment in the abdominal aorta or the iliac arteries for aneurysm or occlusive disease
Planned use of aorto-uni-iliac (AUI) main body device
Any planned additional device (apart from the main body, limb stent graft and extensions per assigned treatment per randomization) during index or staged procedure, e.g., endostaple or anchor, Iliac branch endoprosthesis, embolization, etc.
Planned coverage of the internal iliac artery/arteries
Subject has an estimated glomerular filtration rate (eGFR) \< 45 ml/min/1.73m2 or subject is on dialysis
Subject has a systemic infection who may be at increased risk of endovascular graft infection, per investigator's discretion
Subject has a psychiatric or other condition that may interfere with the trial, per investigator's discretion
Subject is of childbearing potential in whom pregnancy cannot be excluded
Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment
Subject belongs to a vulnerable population per investigator's judgment
Subject has an active COVID-19 infection or relevant history of COVID- 19

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 (NCT05378347) 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.

Abdominal Aortic Aneurysm Treatment Options in Jacksonville, FL

If you're searching for abdominal aortic aneurysm treatment options in Jacksonville, FL, this clinical trial (NCT05378347) 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 abdominal aortic 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 abdominal aortic aneurysm clinical trials near you to find additional studies recruiting in your area.

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