Safety and Effectiveness of Surgeon-Modified Fenestrated and Branched Endografts in Treating Subjects With Complex Aortic Aneurysms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Thoracoabdominal Aneurysm
- Sponsor
- Jesse Manunga, MD
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Prevention of aortic aneurysm related mortality and all cause mortality post intervention
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The primary objective of the present study is to evaluate the safety, effectiveness, and clinical outcomes of surgeon-modified fenestrated stent grafts used to treat patients with failed previous infrarenal repairs (failed EVAR) and complex aortic aneurysms (thoracoabdominal, juxtarenal, pararenal, and paravisceral aneurysms).
Detailed Description
The study is a prospective, non-randomized evaluation of endovascular repair of patients with failed previous infrarenal repairs (failed EVAR) and complex thoracoabdominal/juxtarenal/pararenal/paravisceral aortic aneurysm repair, including those with penetrating ulcers and aneurysms resulting from aortic dissections, who (1) have anatomy that is not suitable for endovascular repair using grafts currently marketed in the United States, (2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair. Depending on the location of the aneurysm, patients with failed EVAR and complex aortic pathology requiring fenestrated and branched endovascular repair will be treated with physician-modified Cook Zenith devices (Zenith Flex, Zenith Fenestrated stent graft (Zfen), Cook Alpha Thoracic Endovascular Graft, Cook dissection TX2), and their associated commercially approved ancillary components. Whenever possible, the Zenith fenestrated universal bifurcated device will be used for patients requiring repair down to the iliac arteries. The Gore Excluder Endoprosthesis or the Gore Iliac Branch Endoprosthesis (IBE) will be used whenever the Zenith universal bifurcated device is not available. Safety and effectiveness will be assessed acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)), at 6 months, at 12 months, and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).
Investigators
Jesse Manunga, MD
Vascular and Endovascular Surgeon
Minneapolis Heart Institute Foundation
Eligibility Criteria
Inclusion Criteria
- •Age: ≥ 18 years old
- •The subject has one or more of the following:
- •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
- •Aneurysm with a history of growth \> 0.5 cm in 6 months or clinically indicated for repair based on symptoms
- •Symptomatic aneurysm
- •Ruptured aneurysm
- •Failed previous EVAR defined as type IA endoleak or increase in aneurysm sac size in the setting of proximal seal loss
- •Saccular aneurysm deemed by the treating vascular specialist at significant risk for rupture
- •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.
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
Outcomes
Primary Outcomes
Prevention of aortic aneurysm related mortality and all cause mortality post intervention
Time Frame: 5 years
Primary outcome criteria: * Mortality related to primary aortic disease and intervention * All-cause mortality post intervention
Secondary Outcomes
- procedure related complication(5 years)
- Issues associated with disease progression, branched instability, endoleak and other disabling complications as evaluated on post-operative follow up and radiographic images.(5 years)
- Endoleak(5 years)
- Issues associated with device migration and failure(years)
- Target vessels instability resulting in adverse events to the patient(5 years)