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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
Life expectancy: ≥2 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months, 1-year, and annually to 5-years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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The part of my aorta closest to my heart is the right size and doesn't have an aneurysm.
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My doctor expects me to live for at least 2 more years.
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I have a type B aortic dissection, had surgery for type A, or have an aortic intramural hematoma.
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I am considered high-risk for open surgery due to my heart/lung health, other illnesses, and the complexity of my anatomy.
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.

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
835 Previous Clinical Trials
13,006,486 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals welcome to join this research project at the present time?

"Affirmative, the clinicaltrials.gov webpage shows that this medical trial is currently recruiting patients and requires 45 participants from 1 site. This study was first made available on March 15th 2021 and has been recently modified on July 25th 2022."

Answered by AI

How many participants have been selected for this clinical trial?

"Affirmative, the clinicaltrial.gov database shows that this medical trial is actively recruiting individuals. It was initially posted on March 15th 2021 and its last update happened on July 25th 2022; 45 patients are needed from one centre."

Answered by AI
~118 spots leftby Dec 2029