Birmingham, ALNCT02043691Now EnrollingIRB Ready

Juxtarenal Aortic Aneurysm Clinical Trial in Birmingham, AL

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

Sponsored by University of Alabama at Birmingham

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Expert Care in Birmingham

Access juxtarenal aortic aneurysm specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related juxtarenal aortic aneurysm treatment provided free

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Check if you qualify for this juxtarenal aortic aneurysm clinical trial in Birmingham, AL

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Why Participate?

  • No-Cost Study Care

  • Local to Birmingham

    Convenient for AL 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 Birmingham site if eligible
  4. 4Begin participation

About This Juxtarenal Aortic Aneurysm Study in Birmingham

This is a single-center study to evaluate the safety and effectiveness of three investigational devices, the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endografts in the treatment of Juxtarenal, Suprarenal, Thoracoabdominal, and Aortic Arch pathologies involving the at least one brachiocephalic artery or visceral vessels. The three investigational devices offer an endovascular approach to treat complex aortic pathologies that cannot be treated with commercially available devices. This customized, endovascular approach has the potential to decrease hospital length of stay, pulmonary complications, and in-hospital mortality.

Sponsor: University of Alabama at Birmingham

Who Can Participate

Inclusion Criteria

Juxtarenal, suprarenal, and thoracoabdominal aortic pathology as follows in hemodynamically stable patients:
Intact or contained ruptured aortic or aortoiliac aneurysms (atherosclerotic/degenerative or saccular) involving or in close approximation to the visceral segment of the aorta.
Diameter \> 5.5 cm if asymptomatic, or 5.0 cm with enlargement of \> 0.5 cm in 6 months.
History of growth \> 0.5 cm per year
Any size if ruptured or symptomatic
Penetrating aortic ulcer (PAU)
\> 2.0 cm in depth
Any size if contained ruptured or symptomatic
Subacute (\>14 days) or chronic (\>20 days) aortic dissection with aneurysmal degeneration with at least one of the following:
Total aortic diameter \> 5.5 cm if asymptomatic
Total aortic diameter \> 4.5 cm if symptomatic
Total aortic diameter \> 5.0 cm and history of growth \> 0.5 cm in 6 months
Aortic Arch pathology:
Aneurysm, Ascending thoracic aortic pseudoaneurysm, Type A thoracic aortic dissection, Retrograde type A thoracic aortic dissection between the Sinus of Valsalva and the innominate artery orifice (without involvement of the Aortic Valve), or Ascending penetrating aortic ulcer with and without intramural hematoma
Suitable iliac artery and brachial artery access
Absence of severe landing zone (\> 90 degree) angulation that would preclude necessary device delivery/seal/fixation.
Suitable iliac artery access to accommodate device delivery system.
Target arteries for arch branches:
\< 24 mm diameter
Adequate landing zone length to obtain proximal and distal seal.
Free from dissection precluding adequate seal in distal landing zone of branch stent and severe tortuosity/thrombus/calcification.
Aortic Arch Aneurysm
Proximal aortic fixation zone:
Native aorta or surgical graft
Diameter: 20 - 42 mm
Proximal neck length \> 20 mm
Must occur distal to coronary arteries and any coronary artery bypass grafts that are considered patent and necessary for proper cardiac perfusion.
Distal aortic fixation zone:
Native aorta or surgical graft
Diameter: 20 - 44 mm
Distal neck length \> 20 mm. However, if dissection, distal graft may land in dissected aorta.
Supra-aortic trunk (brachiocephalic) vessels (Any combination of arteries may be used for repair) A. Innominate artery
Native vessel or surgical graft
Diameter: 8 - 22 mm
Length of sealing zone \> 10 mm
Acceptable tortuosity B. Left (or right) common carotid artery <!-- -->
Native vessel or surgical graft
Diameter 5 - 20 mm
Length of sealing zone \> 10 mm C. Left (or right) subclavian artery <!-- -->
Native vessel or surgical graft
Diameter 5 - 20 mm
Length of sealing zone \> 10 mm
Aortic Dissection
Access into the true lumen from the groin and at least one supra-aortic trunk vessel.
Seal zone in the target aorta (or surgical graft) that is proximal to the primary dissection, such that a stent-graft would be anticipated to seal off the dissection lumen.
Seal zone in the target supra-aortic trunk vessels that is distal to the dissection, anticipated to seal off the dissection lumen or surgically created.
True lumen size large enough to deploy the device and still gain access into the target branch. General

Exclusion Criteria

Less than 18 years of age
Life expectancy less than 12 months based on the surgeon's assessment
Pregnant or breastfeeding or planning on becoming pregnant within 60 months
Inability or refusal to give informed consent
Unwilling or unable to comply with the follow-up schedule
Less than 30 days beyond primary endpoint for other investigative drug or device study Medical Exclusion Criteria:
Known allergy to the device components (i.e. stainless steel, polyester, solder, gold, or nitinol)
History of anaphylactic reaction to contrast material that cannot be adequately premedicated
Systemic or local infection that may increase the risk of endovascular graft infection.
Baseline eGFR \< 30 mL/min (calculated by the Modification of Diet in Renal Disease formula) and not on hemo- or peritoneal dialysis. If the patient is currently on dialysis, or is currently planning on initiating dialysis, then they may undergo repair.
Body habitus that would inhibit X-ray visualization of the aorta.
Major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair.
Unstable angina, defined as a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina.
Irreversible coagulopathy Anatomical Exclusion Criteria:
Aortic transection due to acute trauma.
Infectious ("mycotic") etiology of the aortic disease.
Significant occlusive disease or tortuosity precluding delivery of the device components.
Juxtarenal, Suprarenal, and Thoracoabdominal:
Proximal Landing zone \< 20 mm in length. The proximal landing zone can be within zones 2 through 8, with least 20 mm of proximal seal and fixation in aorta or Dacron.
Proximal neck, defined as the thoracic aorta distal to the native left carotid artery, measured outer wall to outer wall on a sectional image (CT) \> 41 mm in diameter or \< 18 mm in diameter
Distal landing zone \< 20 mm in length if the landing zone is in the aorta, or \< 20 mm if the landing zone is in the iliac arteries or in Dacron (in the event the patient has had a previous or concomitant aortic or aorto-iliac reconstruction).
Untreatable branch vessel stenosis.
Anatomy that would not allow maintenance of at least one patent hypogastric artery.
Signs that the inferior mesenteric artery (IMA) is indispensable (i.e. angiographic visualization or a large IMA, filling of superior mesenteric artery (SMA) via collaterals, stenosis of celiac or SMA or oblique views) and the indispensable IMA is not amenable to treatment with a graft branch or fenestration.
Branching, duplication, aneurysm or untreatable stenosis of the celiac, SMA or renal arteries that would preclude implantation of the investigational devices.
Aortic arch:
Proximal neck \> 44 mm or \< 28 mm in diameter
Inadequate landing zone to allow adequate distal seal of exclusion of false lumen perfusion in dissection.
Untreatable branch vessel stenosis.
Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access.
Patients qualifying for an industry-sponsored study allowing for a similar repair will be enrolled in the industry-sponsored 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 Birmingham?

Yes, this clinical trial (NCT02043691) has an active research site in Birmingham, AL 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.

Juxtarenal Aortic Aneurysm Treatment Options in Birmingham, AL

If you're searching for juxtarenal aortic aneurysm treatment options in Birmingham, AL, this clinical trial (NCT02043691) 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 Birmingham research site is actively enrolling participants for this clinical trial. You'll receive care from experienced juxtarenal 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 juxtarenal aortic aneurysm clinical trials near you to find additional studies recruiting in your area.

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