Evaluation of the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endograft in Treating Aortic Pathologies

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Jan 21, 2014

Keywords

ClinConnect Summary

This clinical trial is looking at three special devices designed to treat serious conditions affecting the aorta, which is the main artery that carries blood from the heart to the rest of the body. These conditions include various types of aortic aneurysms, which are bulges in the aorta that can be dangerous, and penetrating aortic ulcers, which are deep tears in the aorta. The study aims to see if these devices can safely and effectively help patients who are not suitable for standard treatments, potentially leading to shorter hospital stays and fewer complications.

To participate in the trial, patients must be between the ages of 65 and 74 and have specific types of aortic problems while being stable enough for the procedure. Key criteria include having an aneurysm larger than 5.5 cm or experiencing symptoms, and patients with serious health issues or certain anatomical conditions may not be eligible. Participants will receive close monitoring throughout the trial and will contribute to important research that could improve treatment options for others with similar conditions.

Gender

ALL

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 \>0.5cm 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. \>2.0cm in depth
• • 2. Any size if contained ruptured or symptomatic
• 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 \<30mL/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.
• • History of connective tissue disorders.
• • 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.
• • Aortic dissection.
• • Infectious ("mycotic") etiology of the aortic disease.
• • Significant occlusive disease or tortuosity precluding delivery of the device components.
• • Proximal Landing zone \<20mm in length. The proximal landing zone can be within zones 2 through 8, with least 20mm 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 \<20mm in length if the landing zone is in the aorta, or \<20mm 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 is indispensable (i.e. angiographic visualization or a large IMA, filling of SMA via collaterals, stenosis of celiac or SMA or oblique views) and the indispensible 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.