PMEG for Aortic Aneurysm
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byKonstantinos Arnaoutakis, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Konstantinos Dean Arnaoutakis, MD
Disqualifiers: Severe CHF, Unstable angina, Stroke, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of 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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What data supports the effectiveness of the treatment PMEG for Aortic Aneurysm?
Research shows that physician-modified endovascular grafts (PMEG) are effective for treating complex aortic aneurysms, especially in patients who cannot undergo open surgery. Studies indicate that PMEGs provide a survival benefit over other techniques like parallel grafting for certain types of aortic aneurysms.
12345Is the Physician-Modified Endovascular Graft (PMEG) safe for treating aortic aneurysms?
Research shows that Physician-Modified Endovascular Grafts (PMEGs) have been studied for safety in treating aortic aneurysms, particularly in patients who cannot undergo open surgery. These studies suggest that PMEGs are generally safe for use in humans for this condition.
12456How is the treatment PMEG different from other treatments for aortic aneurysm?
PMEG (Physician-Modified Endovascular Graft) is unique because it allows doctors to customize the graft to fit the patient's specific anatomy, making it suitable for those who cannot undergo open surgery. This approach is particularly beneficial for complex aortic aneurysms, where standard grafts may not be effective.
12357Eligibility Criteria
This trial is for adults over 18 with thoracoabdominal or pararenal aortic aneurysms unsuitable for traditional surgery due to health and anatomical reasons. Candidates must have specific artery conditions, adequate access for the device, and expect to live more than a year after repair. Exclusions include severe heart failure, kidney issues not on dialysis, allergies to materials used, poor body imaging conditions, pregnancy/lactation, major upcoming surgeries, participation in other trials within 30 days.Inclusion Criteria
Provision of signed and dated informed consent form
My surgery area is stable for treatment.
I have 5 or fewer non-aneurysmal arteries in my abdomen measuring 4-12mm.
+6 more
Exclusion Criteria
I do not have a bleeding disorder that can't be corrected.
Can be treated in accordance with the instructions for use with a legally marketed endovascular device, including a manufacturer-fabricated custom device
I cannot walk by myself.
+17 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive surgeon-modified endografts for the treatment of pararenal and thoracoabdominal aortic pathology
4 weeks
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
60 months
Multiple visits at Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60
Participant Groups
The trial tests PMEG (surgeon modified endografts) effectiveness and safety in repairing complex aortic aneurysms when standard devices aren't suitable. It focuses on patients who can't undergo conventional open repair because of their anatomy or other health problems that make them high-risk candidates.
1Treatment groups
Experimental Treatment
Group I: Physician-modified endograftsExperimental Treatment1 Intervention
For this clinical protocol, endografts which are commercially available will be modified in a sterile fashion on a back-table in the operating room.
PMEG is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as PMEG for:
- Pararenal aortic aneurysms
- Thoracoabdominal aortic aneurysms
🇪🇺 Approved in European Union as PMEG for:
- Juxtarenal aortic aneurysms
- Thoracoabdominal aortic aneurysms
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of South Florida - South Tampa CampusTampa, FL
Tampa General HospitalTampa, FL
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Who Is Running the Clinical Trial?
Konstantinos Dean Arnaoutakis, MDLead Sponsor
Konstantinos ArnaoutakisLead Sponsor
References
Early report from an investigator-initiated investigational device exemption clinical trial on physician-modified endovascular grafts. [2013]To determine whether a physician-modified endovascular graft (PMEG) is a safe and effective method for treating patients with juxtarenal aortic aneurysms who are deemed unsuitable for open repair.
Physician-modified endovascular grafts for the treatment of elective, symptomatic, or ruptured juxtarenal aortic aneurysms. [2022]To determine if a physician-modified endovascular graft (PMEG) is a safe and effective method of treating juxtarenal aortic aneurysms in patients considered to be unsuitable for open surgical repair.
Physician-Modified Endograft With Inner Branches for the Treatment of Complex Aortic Urgencies. [2022]To describe the use of physician-modified endograft (PMEG) with the exclusive use of inner branches or in combination with fenestrations for the urgent treatment of complex aortic aneurysms.
Systematic Review and Meta-analysis of Physician Modified Endografts for Treatment of Thoraco-Abdominal and Complex Abdominal Aortic Aneurysms. [2022]To perform a systematic review and meta-analysis of the outcomes of physician modified endografts (PMEG) for the treatment of thoraco-abdominal (TAAA) and complex abdominal aortic aneurysms (C-AAA).
Physician-modified endografts are associated with a survival benefit over parallel grafting in thoracoabdominal aneurysms. [2022]Physician-modified endografts (PMEG) and parallel grafting (PG) are important techniques for endovascular repair of complex aortic aneurysms using off-the-shelf devices. However, there are few data regarding the relative efficacy and outcomes of these techniques in thoracoabdominal extent aneurysms. This study sought to compare the outcomes of PG and PMEG across different extents of thoracoabdominal aneurysms (TAAAs) for which they can be used.
Midterm results from a physician-sponsored investigational device exemption clinical trial evaluating physician-modified endovascular grafts for the treatment of juxtarenal aortic aneurysms. [2017]The objective of this study was to report midterm results of an ongoing physician-sponsored investigational device exemption pivotal clinical trial using physician-modified endovascular grafts (PMEGs) for treatment of patients with juxtarenal aortic aneurysms who are deemed unfit for open repair.
Physician-Modified Endograft With Triple Inner Branches for Extensive Aortic Arch Aneurysm. [2022]The purpose of this case report was to demonstrate the feasibility of a physician-modified endograft (PMEG) with 3 inner branches for extensive aortic arch aneurysm.