Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified En… (NCT04746677) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)
United States220 participantsStarted 2021-03-15
Plain-language summary
The primary objective of this study is to examine the safety and effectiveness of physician-modified endovascular grafts (PMEGs) for endovascular repair of complex aortic pathology in high-risk patients. The study is divided into three study arms based on the subject's aortic pathology: (1) Complex abdominal aortic aneurysm (AAA); (2) Thoracoabdominal aortic aneurysm; and (3) Aortic dissection.
Who can participate
Age range21 Years
SexALL
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INCLUSION CRITERIA:
General inclusion criteria (applicable to all 3 study arms):
* Aortic pathology that fits one of the study arms (see below for detailed description)
* Aortic pathology that cannot be treated within the Instructions for Use of an FDA- approved, commercially-available device
* Aortic aneurysm that can be treated within the Instructions for Use of an FDA-approved, commercially-available custom-manufactured device but deemed unsafe to wait the required time for device manufacturing
* Subject is at high-risk of morbidity and mortality with open surgical repair based on cardiopulmonary function, extent of comorbid disease, and anatomic complexity
* Iliac and/or femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories, with or without use of a surgical or endovascular conduit
* Non-aneurysmal aortic segment proximal to the aortic pathology with a:
* Minimum neck length of 20 mm
* Diameter between 20 - 42 mm
* Non-aneurysmal aortic or iliac segment distal to the aortic pathology with:
* Aortic distal fixation site greater than 20 mm in length and diameter between 20-42 mm
* Iliac artery distal fixation site greater than 10 mm in length and diameter range 8- 25 mm
* Age ≥21 years old
* Life expectancy: ≥2 years
Arm1:
* Complex abdominal aortic aneurysm, specifically juxtarenal or suprarenal abdominal aortic aneurysm or type IV thoracoabdominal aortic aneurysm, with maximum diameter of ≥5.5 cm for men…