The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be unsuitable candidates for open surgical repair, have limited or no other options for treatment, and having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device: * acutely (i.e., treatment success and technical success); * at 30 days (i.e., the rate of major adverse events (MAE)); and * at 6 months, 12 months and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).
The primary objective of the clinical investigation Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be unsuitable candidates for open surgical repair, have limited or no other options for treatment, and having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 6 months, 12 months and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
A Physician Modified Endograft is a commercially available, off-the-shelf endograft that has been altered at the time of the procedure by creating fenestrations in the seal zone of the graft to preserve blood flow into vital branch vessels. These fenestrations are marked with medical grade gold markers to facilitate fluoroscopic visualization during the procedure. In order to prevent branch vessel occlusion, these branch vessels are typically stented with covered balloon expandable stents using standardized techniques.
Cleveland Clinic
Cleveland, Ohio, United States
RECRUITINGMajor Adverse Events
The proportion of patients that experience a rate of Major Adverse Events
Time frame: Up to 30 days
Effectiveness
Technical Success, defined as successful delivery and deployment of the physician modified endovascular graft with preservation of those branch vessels intended to be preserved. * Freedom from Type I \& III endoleaks * Freedom from stent graft migration * Freedom from abdominal aortic aneurysm enlargement * Freedom from Aortic aneurysm rupture and conversion to open repair
Time frame: Up to 12 months
Occurrence of the safety events
* Mortality * Aneurysm related mortality * Aneurysm rupture * Major Adverse Events * Renal failure with or without permanent dialysis * Graft infection
Time frame: Up to 5 years
Technical Success
Technical Success is a composite of the following: * Successful access to the arterial system using remote arterial exposure, percutaneous technique, or open surgical conduits * Successful delivery and deployment at the intended implantation site * Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels * Successful withdrawal of the delivery system * Patency of all endovascular graft and stent components * Absence of device deformations requiring unplanned placement of an additional device * Absence of Type I and III endoleaks at completion angiography
Time frame: Up to 30 days
Stent Graft Migratoin
Occurrence of stent graft migration \>10 mm
Time frame: Up to 5 years
All Endoleaks
Occurrence of endoleaks (all types, including Type I and III)
Time frame: Up to 5 years
AAA Enlargement
Occurrence of AAA enlargement
Time frame: Up to 5 years
Patency Related Events
Occurrence of patency related events
Time frame: Up to 5 years
Device Integrity Failure
Occurrence of device integrity failure
Time frame: Up to 5 years
Conversion to Open Repair
Occurrence of Conversion to open repair
Time frame: Up to 5 years
Secondary Intervention
Occurrence of Secondary intervention (reason and type)
Time frame: Up to 5 years
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