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Endovascular Graft

PMEGs for Aortic Aneurysm

N/A
Recruiting
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-aneurysmal aortic segment proximal to the aortic pathology with a minimum neck length of 20 mm and diameter between 20 - 42 mm
Arm3: Acute or chronic type B aortic dissection, prior repair of type A dissection, or aortic intramural hematoma with specified criteria
Must not have
Subject is unwilling to comply with the follow-up schedule
Diagnosis of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months, 1-year, and annually to 5-years
Awards & highlights

Summary

This trial is testing the safety and effectiveness of physician-modified endovascular grafts for endovascular repair of complex aortic pathology in high-risk patients.

Who is the study for?
This trial is for adults over 21 with complex aortic problems like certain aneurysms or dissections, who are at high risk from traditional surgery. They should have specific measurements in their non-aneurysmal aorta and be able to undergo endovascular repair. Pregnant women, those with allergies to device materials, connective tissue disorders, or conditions preventing informed consent are excluded.
What is being tested?
The study tests the safety and effectiveness of custom-tailored grafts (PMEGs) used in minimally invasive procedures for repairing complex aortic pathologies. Participants will be grouped based on their specific aortic condition: abdominal aneurysm, thoracoabdominal aneurysm, or dissection.
What are the potential side effects?
Potential side effects may include complications related to the procedure such as infection risks at the graft site, allergic reactions to materials in the grafts or contrast media used during imaging if not managed properly, and issues arising from improper placement of the graft.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
The part of my aorta closest to my heart is the right size and doesn't have an aneurysm.
Select...
I have a type B aortic dissection, had surgery for type A, or have an aortic intramural hematoma.
Select...
I have a complex aneurysm in my abdomen near my kidneys or chest.
Select...
My aortic condition matches one of the study groups.
Select...
I am 21 years old or older.
Select...
My aorta or iliac artery has a specific size and length suitable for fixation.
Select...
My blood vessels in the hip or thigh area are suitable for medical device insertion.
Select...
I have a type I, II, or III thoracoabdominal aortic aneurysm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am willing to follow the trial's schedule for check-ups and treatments.
Select...
I have been diagnosed with a connective tissue disorder.
Select...
I am allergic to blood thinners or contrast dyes and it can't be managed.
Select...
I cannot have certain procedures due to poor access in my leg arteries.
Select...
My blood vessels are not suitable for a specific graft due to blockage or size.
Select...
I have a blood clotting disorder that cannot be corrected.
Select...
I have had a ruptured aneurysm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months, 1-year, and annually to 5-years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months, 1-year, and annually to 5-years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
All-cause mortality
Aneurysm rupture
Aneurysm-related mortality
+10 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Type B aortic dissectionExperimental Treatment1 Intervention
Includes all Type B dissections
Group II: Thoracoabdominal aortic aneurysm (TAAA)Experimental Treatment1 Intervention
Includes Type I, Type II, and Type III TAAA
Group III: Expanded Selection ArmExperimental Treatment1 Intervention
Includes high risk subjects who do not meet inclusion criteria for Arms !-3
Group IV: Complex abdominal aortic aneurysm (AAA)Experimental Treatment1 Intervention
Includes juxtarenal AAA, suprarenal AAA, and type IV thoracoabdominal aortic aneurysm

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
848 Previous Clinical Trials
12,929,924 Total Patients Enrolled

Media Library

Physician-modified Endovascular Graft (PMEG) (Endovascular Graft) Clinical Trial Eligibility Overview. Trial Name: NCT04746677 — N/A
Thoracoabdominal Aortic Aneurysms Research Study Groups: Expanded Selection Arm, Type B aortic dissection, Thoracoabdominal aortic aneurysm (TAAA), Complex abdominal aortic aneurysm (AAA)
Thoracoabdominal Aortic Aneurysms Clinical Trial 2023: Physician-modified Endovascular Graft (PMEG) Highlights & Side Effects. Trial Name: NCT04746677 — N/A
Physician-modified Endovascular Graft (PMEG) (Endovascular Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04746677 — N/A
~108 spots leftby Dec 2029
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