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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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I have an aneurysm in the upper part of my aorta.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of subjects with 30-day major adverse events from primary procedure
Number of subjects with treatment success
Secondary outcome measures
Number of subjects with mortality, major adverse events, spinal cord ischemia
Number of subjects with treatment success and freedom from secondary intervention
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.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a bleeding disorder that can't be corrected.I cannot walk by myself.My surgery area is stable for treatment.I have 5 or fewer non-aneurysmal arteries in my abdomen measuring 4-12mm.I am 18 years old or older.My kidney function is low, and I am on or will start dialysis.I have severe narrowing or hardening of my pelvic arteries and cannot have a bypass.I have severe heart failure.My treatment involves covering major arteries near my stomach with a special device.The object landed too close to zone 0 or 1.I have unstable chest pain.I am expected to live more than a year after my aneurysm repair.I have an aneurysm in the upper part of my aorta.I have a burst blood vessel causing unstable blood pressure.I have a major surgery planned within 30 days after my vessel repair.I cannot keep at least one main artery in my lower abdomen open.Your bones need to be strong enough to support the treatment.I do not have an ongoing infection or fungal aneurysm.My arteries are suitable for the required medical procedure.I am not pregnant or breastfeeding.Your body shape makes it difficult to see your aorta clearly using a special imaging technique.My aorta has moderate to severe calcification, blood clots, or is very twisted.I have not had a stroke or heart attack in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Physician-modified endografts
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current opportunities for patients to become involved in this research endeavor?
"According to information published on clinicaltrials.gov, this medical study is not recruiting participants at present. Initially posted in July 1st 2022 and updated as recently as May 16th 2022, the trial has ceased its recruitment process; however, 152 other studies are currently enrolling patients."
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