Boca Raton, FLNCT01524211Now EnrollingIRB Ready

Thoracoabdominal Aortic Aneurysm Clinical Trial in Boca Raton, FL

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

Sponsored by Baptist Health South Florida

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Expert Care in Boca Raton

Access thoracoabdominal aortic aneurysm specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related thoracoabdominal aortic aneurysm treatment provided free

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Check if you qualify for this thoracoabdominal aortic aneurysm clinical trial in Boca Raton, FL

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Why Participate?

  • No-Cost Study Care

  • Local to Boca Raton

    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 Boca Raton site if eligible
  4. 4Begin participation

About This Thoracoabdominal Aortic Aneurysm Study in Boca Raton

Zenith t-Branch Study Cohort: The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular stent-graft system and the Terumo Arch Branch for the treatment of aortic aneurysms. Terumo Arch Branch Study Cohort: The purpose of this additional study arm to the current IDE clinical trial is to collect a priori information on the Terumo Arch Branch Endograft for the treatment of proximal thoracic aortic pathologies that cannot be treated with conventional thoracic endografts.

Sponsor: Baptist Health South Florida

Who Can Participate

Inclusion Criteria

The patient must have one of the following:
Degenerative, atherosclerotic thoracoabdominal, suprarenal and juxtarenal aortic aneurysms (fusiform or saccular):≥55mm in diameter in a male or ≥50mm in diameter in a female, or
Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or
Penetrating ulcers: ≥20mm in depth or
Chronic type B aortic dissections: ≥50mm total aortic diameter or
Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size. Additional criteria for LP material • Iliofemoral access vessels \<8mm or with significant atherosclerotic occlusive disease that would require an iliac conduit as determined by the Principle Investigator

Exclusion Criteria

General Criteria
Life-expectancy less than 12 months
Refusal to receive blood products
Age \<18 years
Pregnant or breastfeeding or planning on becoming pregnant within 60 months
Unwilling to comply with the follow-up schedule
Inability or refusal to give informed consent by subject and/or Legally Authorized Representative (LAR); should one be utilized Medical Criteria
Uncontrolled systemic infection
Untreatable malignancy
Uncontrollable anaphylaxis to iodinated contrast
Known allergy(ies) to device materials Anatomic Criteria
Any pathology of mycotic origin
Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)
Inability to insert the Zenith® t-Branch device through iliofemoral approach
Proximal and distal neck angle less than 90 degrees relative to the long axis of the aneurysm
Proximal landing zone length \<25mm to allow secure fixation and seal
Proximal landing zone diameter of \<24mm or \>42mm
Distal landing zone length \<25mm in the abdominal aorta or \<20mm in the iliac arteries
Distal landing zone diameter of \<14mm or \>30mm in the abdominal aorta, or \<7mm or \>28mm in the iliac arteries Terumo Arch Branch Eligibility Criteria Inclusion Criteria The subject must have one of the following:
Degenerative, atherosclerotic aneurysm involving the ascending aorta, aortic arch or proximal descending aorta ≥55 mm in diameter or \> 50 mm with a history of growth ≥5 mm in the last 6 months, or
Penetrating ulcers: ≥20 mm in depth, or
Chronic aortic dissections: ≥50mm total aortic diameter. AND Prohibitive or high-risk for standard open surgical repair, defined as having one or more of the following pre-existing conditions.
Age \>85 years old.
Prior median sternotomy (for any reason).
Prior open or endovascular thoracic aortic repair.
Severe aortic calcification.
Severe occlusive disease of one or more arch vessels.
Moderate-severe COPD (FEV1 \<80% predicted).
Severe CKD (Stage 3 or greater, eGFR \<60 mL/min).
LV dysfunction.
Chronic steroid or immunosuppressive use.
History of increased risk of bleeding.
Neurocognitive deficits that may significantly impact postoperative rehabilitation.
Musculoskeletal conditions that may significantly impact postoperative rehabilitation. Exclusion Criteria General Criteria
Life expectancy \<1 year.
Refusal to receive blood products.
Age \<18 years.
Pregnant, breastfeeding, or planning to become pregnant within 60 months.
Unwilling to comply with the follow-up schedule.
Inability or refusal to give informed consent by subject and/or Legally Authorized Representative (LAR); should one be utilized.
Willingness to travel, if needed, to participate in a manufacturer-sponsored clinical trial at another institution. Medical Criteria
Pending cardiac surgery.
Untreatable severe, symptomatic coronary or valvular disease.
Prior mechanical aortic valve replacement (not bioprosthetic).
History of TAVR (Transcatheter Aortic Valve Replacement)
Severe, calcific aortic valvular stenosis.
Uncontrolled systemic infection.
Untreatable malignancy with \<1 year expected survival.
Uncontrollable anaphylaxis to iodinated contrast.
Known allergy(ies) to device materials. (i.e. polyester, nitinol). Anatomic Criteria
Any pathology of mycotic origin.
Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial).
Acute (\<2 weeks) aortic dissection.
Type A dissection.
Symptomatic or ruptured pathology.
Anatomy suitable for repair using commercially-available endograft.
Inability to insert the Arch Branch endograft through an iliofemoral approach.
Untreated, known extracranial carotid stenosis \>80%.
Ascending aortic angulation with radius of curvature \<15mm in the intended landing zone.
Proximal aortic landing zone length \<25 mm.
Proximal aortic landing zone diameter of \>43mm or \<28 mm.
Distal aortic landing zone diameter \<20 mm.
Total length along the outer curve from the distal coronary to the proximal edge of the brachiocephalic trunk \<70mm.
Target arch vessels:
Distal branch landing zone dimensions: I. Brachiocephalic trunk (innominate artery, BCT): Diameter \>24 mm or \<6 mm, length \<15 mm. ii. Common carotid artery: Diameter \<6 mm, length \<25mm. iii. Subclavian artery: Diameter \<6 mm, length \<25mm.

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 Boca Raton?

Yes, this clinical trial (NCT01524211) has an active research site in Boca Raton, 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.

Thoracoabdominal Aortic Aneurysm Treatment Options in Boca Raton, FL

If you're searching for thoracoabdominal aortic aneurysm treatment options in Boca Raton, FL, this clinical trial (NCT01524211) 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 Boca Raton research site is actively enrolling participants for this clinical trial. You'll receive care from experienced thoracoabdominal 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 thoracoabdominal aortic aneurysm clinical trials near you to find additional studies recruiting in your area.

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