PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKonstantinos Dean Arnaoutakis, MD
About this trial
The primary objective is to evaluate the safety and effectiveness of surgeon modified endografts for the treatment of pararenal and thoracoabdominal aortic pathology in patients who are not candidate for traditional open repair due to comorbid issues and their anatomy is not amenable to commercially available endografts.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form
Male or female, aged ≥18 years
Expected survival beyond 1 year following successful aneurysm repair
Anatomy that would require coverage of the celiac artery, superior mesenteric artery (SMA), and/or renal arteries if conventional, FDA-approved endograft were implanted to obtain adequate sealing zone length
Disqualifiers
Moderate-to-severe aortic neck calcification, thrombus, or tortuosity
Severe iliac stenosis, calcification, or tortuosity with no ability to perform a conduit
Proximal landing within zone 0 or 1
Inability to maintain at least one patent hypogastric artery
Trial design
Design model
Single group
Treatments tested in this trial
PMEG
DeviceAll devices that will be modified in this study protocol are commercially available in the United States. The commercially available endografts will be used to construct a fenestrated/branched device for this intervention.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Physician-modified endograftsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of subjects with 30-day major adverse events from primary procedure
Major adverse events include: aortic-related mortality, major stroke, myocardial Infarction, permanent spinal cord ischemia, renal failure, bowel Ischemia (requiring laparotomy/bowel resection), respiratory failure (mechanical ventilation \>72 hours or requiring tracheostomy), lower extremity ischemia, blood loss ≥1,000cc
Time frame
Day 302
Number of subjects with treatment success
Treatment success is defined as a composite of: technical success, device integrity (freedom from stent fractures), freedom from aortic enlargement ≥5mm compared to preoperative CT imaging, freedom from aortic rupture, freedom from reintervention for type I or III endoleak or patency-related event, freedom from conversion to open aneurysm repair, freedom from aneurysm-related mortality.
Time frame
Month 12Secondary outcomes
1
Number of subjects with mortality, major adverse events, spinal cord ischemia
Mortality includes all-cause mortality. Major adverse events include: aortic-related mortality, major stroke, myocardial Infarction, permanent spinal cord ischemia, renal failure, bowel Ischemia (requiring laparotomy/bowel resection), respiratory failure (mechanical ventilation \>72 hours or requiring tracheostomy), lower extremity ischemia, blood loss ≥1,000cc. Spinal cord ischemia data will include all incidence and degree of spinal cord ischemia.
Time frame
Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 602
Number of subjects with treatment success and freedom from secondary intervention
Treatment success is defined as a composite of: technical success, device integrity (freedom from stent fractures), freedom from aortic enlargement ≥5mm compared to preoperative CT imaging, freedom from aortic rupture, freedom from reintervention for type I or III endoleak or patency-related event, freedom from conversion to open aneurysm repair, freedom from aneurysm-related mortality. Freedom from secondary interventions includes interventions to treat malperfusion, rupture, aneurysm formation, aortic expansion, endoleak, device stenosis/occlusion, or access site complication.
Time frame
Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Konstantinos Dean Arnaoutakis, MD
Lead sponsor
University of South Florida
Sponsor institution
Source ClinicalTrials.gov