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Endovascular Device

PMEG for Aortic Aneurysm

N/A
Recruiting
Led By Konstantinos Arnaoutakis, MD
Research Sponsored by Konstantinos Dean Arnaoutakis, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No more than 5 non-aneurysmal visceral (celiac, SMA, or renal) arteries with diameters between 4-12mm
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
Must not have
Uncorrectable coagulopathy or other bleeding diathesis
Non-ambulatory status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new type of endograft for people with aortic pathology who are not candidates for traditional open repair.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, similar procedures may involve risks like infection at the incision site, allergic reactions to device materials or contrast agents used during surgery; complications related to organ systems covered by the graft such as kidneys; bleeding; blood vessel damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have 5 or fewer non-aneurysmal arteries in my abdomen measuring 4-12mm.
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My treatment involves covering major arteries near my stomach with a special device.
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I am expected to live more than a year after my aneurysm repair.
Select...
I have an aneurysm in the upper part of my aorta.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have a bleeding disorder that can't be corrected.
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I cannot walk by myself.
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My kidney function is low, and I am on or will start dialysis.
Select...
I have severe narrowing or hardening of my pelvic arteries and cannot have a bypass.
Select...
I have severe heart failure.
Select...
I have unstable chest pain.
Select...
I have a burst blood vessel causing unstable blood pressure.
Select...
I have a major surgery planned within 30 days after my vessel repair.
Select...
I cannot keep at least one main artery in my lower abdomen open.
Select...
I do not have an ongoing infection or fungal aneurysm.
Select...
I am not pregnant or breastfeeding.
Select...
My aorta has moderate to severe calcification, blood clots, or is very twisted.
Select...
I have not had a stroke or heart attack in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of subjects with 30-day major adverse events from primary procedure
Number of subjects with treatment success
Secondary study objectives
Number of subjects with mortality, major adverse events, spinal cord ischemia
Number of subjects with treatment success and freedom from secondary intervention

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Konstantinos Dean Arnaoutakis, MDLead Sponsor
Konstantinos ArnaoutakisLead Sponsor
Konstantinos Arnaoutakis, MDPrincipal InvestigatorUniversity of South Florida
2 Previous Clinical Trials
10 Total Patients Enrolled

Media Library

PMEG (Endovascular Device) Clinical Trial Eligibility Overview. Trial Name: NCT05195905 — N/A
Thoracoabdominal Aortic Aneurysms Research Study Groups: Physician-modified endografts
Thoracoabdominal Aortic Aneurysms Clinical Trial 2023: PMEG Highlights & Side Effects. Trial Name: NCT05195905 — N/A
PMEG (Endovascular Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05195905 — N/A
~20 spots leftby Feb 2029
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