The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be high risk candidates for open surgical repair, have limited or no other options for on label treatment with an FDA approved device, and having appropriate anatomy.
Patient is ≥ 18 years of age
Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form
An aneurysm with a maximum diameter of ≥ 5.5 cm for male (≥ 5.0 cm for female) or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
Patient has a mycotic aneurysm or has an active systemic or local infection that may increase the risk of endovascular infection
Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
Patient has a major surgical or interventional procedure, not related to the endovascular repair, planned within +/- 30 days of the AAA repair.
Patient has history of an aortopathic connective tissue disease (e.g. Marfan's or Ehler's-Danlos syndrome).
Single group
Physician Modified Aortic Endograft repair for complex aortic aneurysm
DeviceTo 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.
Primary Safety Endpoint: Safety of PMEG device will be measured by proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure.
The Primary Safety Endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure. Major Adverse Events that will be recorded include the following: * All-cause mortality * Myocardial Infarction * Stroke * Renal Failure * Respiratory Failure * Paraplegia * Bowel Ischemia * Procedural Blood Loss (\> 1000cc)
Primary Effectiveness Endpoint: Will be measured by calculating the proportion of patients that achieve Treatment Success
Effectiveness of the PMEG device will be measured by the calculating the proportion of subjects that achieve Treatment Success. Treatment Success is a will be assessed at 12 months and is define by a combination of following criteria to be met: * Technical Success (at the index procedure). * Freedom from Type I \& III endoleaks at 12 months * Freedom from stent graft migration at 12 months * Freedom from aortic aneurysm enlargement at 12 months * Freedom from aortic aneurysm rupture and conversion to open repair through 12 months Technical Success at the index procedure will be defined by: The physician was able to insert the delivery catheter and deliver the physician modified endovascular graft to the treatment site and preserve blood flow into the vessels intended to have blood flow preserved.
Secondary Safety Endpoints: Will be assessed by measuring proportion of patients encountering any of the following adverse events
The adverse events will be evaluated at 30 days, 6 months, 12 months following the initial implant procedure and annually through 5 years. The adverse events to be evaluated include: * Mortality * Aneurysm related mortality * Aneurysm rupture * Major Adverse Events (MAE) * Renal Failure with or without permanent dialysis * Graft infection
Secondary Effectiveness Endpoints: Defined by proportion of patients experiencing the following events.
The secondary effectiveness endpoints will be evaluated at 30 days, 6 months, 12 months following the initial implant procedure and annually through 5 years: Following secondary endpoints will be evaluated for every patient: * Technical Success (evaluated at 30-days) * Stent graft migration (\>10 mm) * All endoleaks, including Type I \& III endoleaks * AAA enlargement * Patency related events * Device integrity failure * Conversion to open repair * Secondary intervention (reason and type)
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Akhilesh Jain
Lead sponsor
Hartford Hospital
Sponsor institution
