Evaluating new endografts for treating complex aortic conditions

Evaluation of All-Cause Mortality and Pulmonary Morbidity in Treating Juxtarenal, Suprarenal, Thoracoabdominal, and Aortic Arch Pathologies Using Cook Custom Aortic Endografts, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endograft

This study is testing new types of stents for people with complicated aortic conditions to see if they are safe and effective compared to standard treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 410 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Alabama at Birmingham (Academic / other)
• Locations: 1 site (Birmingham, Alabama)
• Trial ID: NCT02043691 on ClinicalTrials.gov

What this trial studies

This study assesses the safety and effectiveness of three investigational endografts designed for treating complex aortic pathologies that are not suitable for standard devices. Participants will undergo a series of tests, including clinical exams and imaging, to determine eligibility and the appropriate device for their condition. The study aims to follow participants for five years to evaluate outcomes such as hospital stay duration and complication rates.

Who should consider this trial

Good fit: Ideal candidates include adults with juxtarenal, suprarenal, or thoracoabdominal aortic pathologies that are hemodynamically stable.

Not a fit: Patients under 18 years of age or those with a life expectancy of less than 12 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with complex aortic conditions, potentially reducing complications and hospital stays.

How similar studies have performed: Other studies have shown promise with similar endovascular approaches, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

* Juxtarenal, suprarenal, and thoracoabdominal aortic pathology as follows in hemodynamically stable patients:

  1. Intact or contained ruptured aortic or aortoiliac aneurysms (atherosclerotic/degenerative or saccular) involving or in close approximation to the visceral segment of the aorta.

     1. Diameter \> 5.5 cm if asymptomatic, or 5.0 cm with enlargement of \> 0.5 cm in 6 months.
     2. History of growth \> 0.5 cm per year
     3. Any size if ruptured or symptomatic
  2. Penetrating aortic ulcer (PAU)

     1. \> 2.0 cm in depth
     2. Any size if contained ruptured or symptomatic
  3. Subacute (\>14 days) or chronic (\>20 days) aortic dissection with aneurysmal degeneration with at least one of the following:

     1. Total aortic diameter \> 5.5 cm if asymptomatic
     2. Total aortic diameter \> 4.5 cm if symptomatic
     3. Total aortic diameter \> 5.0 cm and history of growth \> 0.5 cm in 6 months
* Aortic Arch pathology:

  1. 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
  2. Suitable iliac artery and brachial artery access
  3. Absence of severe landing zone (\> 90 degree) angulation that would preclude necessary device delivery/seal/fixation.
  4. Suitable iliac artery access to accommodate device delivery system.
  5. Target arteries for arch branches:

     1. \< 24 mm diameter
     2. Adequate landing zone length to obtain proximal and distal seal.
     3. Free from dissection precluding adequate seal in distal landing zone of branch stent and severe tortuosity/thrombus/calcification.
* Aortic Arch Aneurysm

  1. Proximal aortic fixation zone:

     1. Native aorta or surgical graft
     2. Diameter: 20 - 42 mm
  2. Proximal neck length \> 20 mm
  3. Must occur distal to coronary arteries and any coronary artery bypass grafts that are considered patent and necessary for proper cardiac perfusion.
  4. Distal aortic fixation zone:

     1. Native aorta or surgical graft
     2. Diameter: 20 - 44 mm
  5. Distal neck length \> 20 mm. However, if dissection, distal graft may land in dissected aorta.
  6. Supra-aortic trunk (brachiocephalic) vessels (Any combination of arteries may be used for repair) A. Innominate artery

     1. Native vessel or surgical graft
     2. Diameter: 8 - 22 mm
     3. Length of sealing zone \> 10 mm
     4. Acceptable tortuosity B. Left (or right) common carotid artery

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     1. Native vessel or surgical graft
     2. Diameter 5 - 20 mm
     3. Length of sealing zone \> 10 mm C. Left (or right) subclavian artery

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     1. Native vessel or surgical graft
     2. Diameter 5 - 20 mm
     3. Length of sealing zone \> 10 mm
* Aortic Dissection

  1. Access into the true lumen from the groin and at least one supra-aortic trunk vessel.
  2. 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.
  3. 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.
  4. 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.

Where this trial is running

Birmingham, Alabama

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)

Study contacts

• Principal investigator: Adam W Beck, MD — University of Alabama at Bimingham
• Study coordinator: Adam W Beck, MD

Conditions Juxtarenal Aortic Aneurysm; Suprarenal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm; Penetrating Aortic Ulcer; Aortic Arch Aneurysm; Aortic Dissection; Endovascular; Aortic