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Stent Graft
Endovascular Stent Grafts for Aortic Aneurysm
N/A
Recruiting
Led By Darren Schneider, MD
Research Sponsored by Darren Schneider, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of TAAA in men with TAAA larger than 5 cm in diameter and enlarging at a rate of more than 10mm/year
Presence of TAAA in women with TAAA larger than 4.5 cm in diameter and enlarging at a rate of more than 10mm/year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up yearly through 5 years
Awards & highlights
Study Summary
This trial is testing whether a less invasive surgery to fix aortic aneurysms is safe and effective.
Who is the study for?
This trial is for adults with thoracoabdominal aortic aneurysms (TAAA) that are large or growing quickly, and who are at high risk for open surgery. Candidates must have a life expectancy over 2 years, be able to consent and follow the study plan, and have suitable anatomy for the treatment. Pregnant women, those under 18, patients with certain allergies or conditions like Marfan Syndrome can't join.Check my eligibility
What is being tested?
The study tests endovascular treatments using special stent grafts on complex aortic aneurysms in two groups: one with TAAA and another with aortic arch aneurysms. It's not randomized; participants aren't chosen by chance but based on their condition suitability.See study design
What are the potential side effects?
While specific side effects aren't listed here, endovascular procedures may include risks such as bleeding, infection at the incision site, damage to blood vessels or organs near the aneurysm, clotting issues leading to stroke or limb loss.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man with a thoracic aortic aneurysm larger than 5 cm that's growing quickly.
Select...
I am a woman with a rapidly growing TAAA larger than 4.5 cm.
Select...
My arteries are fit for a specific type of aneurysm repair.
Select...
I am considered high risk for traditional surgery.
Select...
I have a thoracoabdominal aortic aneurysm and an iliac artery aneurysm larger than 4 cm.
Select...
I am a man with a thoracoabdominal aortic aneurysm (TAAA) that is 6 cm or larger.
Select...
I am a woman with a thoracoabdominal aortic aneurysm (TAAA) that is 5 cm or larger.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ yearly through 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~yearly through 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom from aneurysm-related mortality at 1 year
Procedural Success
Technical Success
+1 moreSecondary outcome measures
Freedom from all-cause mortality
Freedom from amputation
Freedom from aneurysm dilatation
+11 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: TAAA (thoracoabdominal aortic aneurysm) Study ArmExperimental Treatment1 Intervention
Either the Off-the-Shelf TAAA device or the Physician-Specified TAAA Device will be implanted.
The Off-the-Shelf TAAA Device is a standard configuration Zenith t-Branch with four branches for the mesenteric arteries and the renal arteries.
The Physician-Specified TAAA Devices may include a combination of up to 5 fenestrations and branches for mesenteric and renal arteries. Branches will be used for downward-oriented mesenteric and renal arteries and fenestrations for renal arteries that project laterally or upwards.
Group II: Aortic Arch Study ArmExperimental Treatment1 Intervention
Physician-specified double inner branch stent-graft with or without retrograde left subclavian branch or a physician-specified retrograde left subclavian branch stent-graft with double or triple wide scallop to the left common carotid artery.
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Who is running the clinical trial?
Darren Schneider, M.D.Lead Sponsor
Darren Schneider, MD4.986 ReviewsPrincipal Investigator - University of Pennsylvania
University of Pennsylvania
1 Previous Clinical Trials
64 Total Patients Enrolled
5Patient Review
Dr. Darren Schneider and the entire staff at Weill Cornell medical Center are extremely professional and deliver great patient care. I would highly recommend him and his team to anyone.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.You are expected to live for more than 2 years.I have a blood clotting disorder that cannot be corrected.I have not had major surgery or procedures within the last 30 days.Your body shape makes it difficult to see your aorta clearly on X-rays.I have been diagnosed with an acute aortic dissection.I am a woman with a rapidly growing TAAA larger than 4.5 cm.My arteries are fit for a specific type of aneurysm repair.I am a man with a thoracic aortic aneurysm larger than 5 cm that's growing quickly.I am considered high risk for traditional surgery.I have a serious infection in my body or groin area.I have a thoracoabdominal aortic aneurysm and an iliac artery aneurysm larger than 4 cm.I have a condition like Marfan or Ehler-Danlos Syndrome.I am a man with a thoracoabdominal aortic aneurysm (TAAA) that is 6 cm or larger.I cannot follow the trial's follow-up schedule.I have experienced a rupture leading to low blood pressure (below 90).I am a woman with a thoracoabdominal aortic aneurysm (TAAA) that is 5 cm or larger.I have an infection in the wall of my artery.
Research Study Groups:
This trial has the following groups:- Group 1: TAAA (thoracoabdominal aortic aneurysm) Study Arm
- Group 2: Aortic Arch Study Arm
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 any participants being recruited presently for this research endeavor?
"According to the latest information on clinicaltrials.gov, this trial is still recruiting participants with a date of first posting noted as November 1st 2013 and last edited October 3rd 2022."
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