Safety and Effectiveness of Surgeon-Modified Stent Grafts forTreatment of Complex Aortic Aneurysms

Launched by JESSE MANUNGA, MD · Sep 2, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of a special type of stent graft, which is a tube made of fabric and metal, modified by surgeons to treat complex aortic aneurysms. An aortic aneurysm is a bulge in the aorta, the main blood vessel that carries blood from the heart. This study specifically focuses on patients who have had previous unsuccessful repairs of their aneurysms and are at high risk for traditional surgery. The goal is to see if these modified stent grafts can help improve the health and outcomes for these patients.

To participate in this trial, individuals must be at least 18 years old and have specific types of aneurysms that meet certain size and growth criteria. They should also have experienced issues with previous repairs or be deemed high-risk for open surgery. Participants can expect to receive careful monitoring and follow-up care during the trial. This study is not yet recruiting participants, so there will be more information available later on how to enroll if eligible. It's important to note that this trial aims to provide new options for patients who currently have limited treatment choices due to the complexity of their condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: ≥ 18 years old
• * The subject has one or more of the following:
• 1. An aneurysm with a maximum diameter of \> 5.5 cm (in men) and 5 cm (in women) or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e, perpendicular to the centerline) measurements 2. Aneurysm with a history of growth \> 0.5 cm in 6 months or clinically indicated for repair based on symptoms 3. Symptomatic aneurysm 4. Ruptured aneurysm 6. Failed previous EVAR defined as type IA endoleak or increase in aneurysm sac size in the setting of proximal seal loss 7. Saccular aneurysm deemed by the treating vascular specialist at significant risk for rupture 8. High risk for open surgical repair based on any of the factors below:
• • a. Anatomic i. Previous abdominal surgery ii. Previous left-sided thoracotomy (if the proposed open repair would require dissection of the thoracic aorta) iii. Previous aortic surgery b. Physiological high risk For this IDE, physiological risk will be assessed using two systems. First, this study will use the Society for Vascular Surgery (SVS)/American Association for Vascular Surgery (AAVS) medical comorbidity grading system recommended for use by the SVS to describe the severity of medical comorbidities in patients with complex aortic aneurysm disease. However, as the current SVS/AAVS grading system has yet to be validated in prospective studies or in a large cohort of patients treated for aortic disease, the American Association of Anesthesiologists grading system will also be utilized due to its widely adopted use and simplicity although it relies on subjective parameters and lacks specific metrics that affect outcomes.
• • American Association of Anesthesiologists grading system: subjects with ASA scores of 3-5 will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; subjects with ASA scores of 6 will be excluded.
• • SVS/AAVS grading system: high risk (8-20% mortality risk) subjects will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; prohibitive high risk (31-70% mortality risk) subjects will be excluded.
• • Medical Inclusion Criteria
• • American Association of Anesthesiologists (ASA) physical status classification system: subjects with ASA scores of 1-5 will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; subjects with ASA scores of 6 will be excluded.
• • SVS/AAVS grading system: low risk (0.12-1% mortality risk), medium risk (1.7-4.9% mortality risk), and high risk (8-20% mortality risk) subjects will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; prohibitive high risk (31-70% mortality risk) subjects will be excluded.
• • Anatomical Inclusion Criteria
• • Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories, with or without use of a surgical conduit
• • Extent of aorta to be treated: infrarenal aortic aneurysms with \< 10 mm neck length, juxtarenal or pararenal aneurysms that include 1 or 2 renal arteries; paravisceral and extent IV-V thoracoabdominal aneurysms, Extent I-III thoracoabdominal aneurysm including those patients requiring a carotid-left subclavian bypass in order to achieve, at least, 20 mm of proximal landing zone
• * Non-aneurysmal aortic segment proximal to the aneurysm (neck) with a:
• • 1. Minimum neck length of 20 mm
• • 2. Diameter in the range of 20 mm - 38 mm
• • 3. Angle less than 60 degrees relative to the axis of the aneurysm
• • 4. Angle less than 60 degrees relative to the axis of the suprarenal aorta
• • Minimum branch vessel diameter of 5 mm or greater Iliac artery distal fixation site greater than 45 mm in length and diameter in the range of 8 mm to 17 mm
• Exclusion Criteria:
• • Age: \< 18 years old
• • Does not meet the above inclusion criteria
• • Can be treated in accordance with the instructions for use with a commercially approved and marketed endovascular prosthesis
• • Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site with the exception of percutaneous aortic valve surgery
• • Unwilling or unable to comply with the follow-up schedule
• • Inability or unwillingness of patient or patient's legally authorized representative to provide informed consent.
• • Subject is pregnant or breastfeeding
• • Any other circumstance or condition which, at the discretion of the sponsor-investigator, makes the patient unsuitable for inclusion Medical Exclusion Criteria
• • Known sensitivities or allergies to the materials of construction of the devices, including but not limited to titanium and PTFE.
• • Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
• • Uncorrectable coagulopathy
• • Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
• • Subject has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned \< 30 days of the endovascular repair
• • Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest, or nocturnal angina)
• • Systemic or local infection that may increase the risk of endovascular graft infection
• • Baseline creatinine greater than 2.0 mg/dL
• • History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome) with the exception of patients who have had prior open surgical aortic replacement where a surgical graft would serve as a "landing zone" for the investigational stent-graft Anatomical Exclusion Criteria
• • 1. Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access
• • 2. Proximal neck length ≤20 mm
• • 3. Proximal neck, measured outer wall to outer wall on a sectional image (CT)
• • 1. For use of Zenith Fenestrated: diameter \>32 mm or \<18 mm
• • 2. For use of Zenith Alpha Thoracic: diameter \>38 mm or \<18 mm (for proximal and distal neck diameter)
• • 3. Zenith TX2 Dissection Endovascular graft: diameter 38 mm or \<18 mm
• • 4. Zenith Flex AAA endovascular graft: diameter \>32 mm or \< 18 mm
• • 4. Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm
• • 5. Proximal neck diameter changes over the length of the proximal seal zone \>4 mm
• • 6. Proximal seal site with a circumferential thrombus/atheroma
• • 7. Iliac artery diameter, measured inner wall to inner wall on a sectional image (CT) \<7.0 mm at any point along access length (prior to deployment)
• • 8. Ipsilateral iliac artery fixation site diameter, measured inner wall on a sectional image (CT) \>21 mm at distal fixation site
• • 9. Iliac artery distal fixation site \<10 mm in length
• • 10. Non-bifurcated segment of any artery to be stented \< 15 mm in length
• • 11. Artery to be stented with a maximum diameter \<3 mm or \>10 mm at the vessel ostium
• • 12. Inability to maintain at least one patent hypogastric artery
• • 13. Bilateral renal artery stenosis \>80%
• • 14. Superior mesenteric artery stenosis \>80%