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Endovascular Device
Modified Aortic Endograft for Aortic Aneurysm
N/A
Waitlist Available
Led By David P. Kuwayama, M.D., M.P.A.
Research Sponsored by David P. Kuwayama
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have a thoracoabdominal aortic aneurysm of any Crawford classification (extent I-V) that extends no more proximal than the left subclavian artery
Must have an aneurysm size that meets standard indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is testing a new type of aortic aneurysm surgery to see if it's safe and effective.
Who is the study for?
This trial is for men and women over 50 with thoracoabdominal aortic aneurysms who are high-risk candidates for open surgery and not suitable for FDA-approved endovascular grafts. Participants must be able to follow a five-year study plan, have life expectancy over two years, and meet size criteria for surgical repair.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of a modified Cook Zenith Alpha Thoracic Endovascular Graft in treating thoracoabdominal aortic aneurysms. It aims to show that this approach is as good or better than traditional open surgical replacement.See study design
What are the potential side effects?
Potential side effects may include complications related to the implantation procedure such as infection, bleeding, blood vessel damage, allergic reactions to device materials (stainless steel, PTFE, polyester), or issues due to blockage or movement of the graft.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have an aortic aneurysm that does not extend beyond my left subclavian artery.
Select...
My aneurysm is large enough to require surgery.
Select...
I need treatment for an aneurysm in my chest or abdomen that affects major arteries.
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I am 50 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
30 day survival
Major Adverse Events (MAE) at 30 days following surgery
Technical success at 12 months following surgery
+1 moreSecondary outcome measures
Access site complication (Femoral or Iliac)
Aneurysm rupture
Conversion to open repair
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Main Arm - Physician-modified fenestrated endovascular graftExperimental Treatment1 Intervention
Use of a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair.
Group II: Expanded Access Arm - Physician-modified fenestrated endovascular graft.Experimental Treatment1 Intervention
Use of a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal, thoracic, or abdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair in an expanded use population.
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Who is running the clinical trial?
David P. KuwayamaLead Sponsor
David P. Kuwayama, M.D., M.P.A.5.01 ReviewsPrincipal Investigator - Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
5Patient Review
Dr. Kuwayama is an excellent physician who has repeatedly gone above and beyond for me. I'm grateful to have him in my life.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have unstable chest pain.The doctor thinks you are at high risk for a specific type of surgery.I have an aortic aneurysm that does not extend beyond my left subclavian artery.My aneurysm is large enough to require surgery.I need treatment for an aneurysm in my chest or abdomen that affects major arteries.My aneurysm is large enough or at high risk of bursting, needing surgery.You have a known condition that affects your connective tissues.The area where the device will be placed is too short and may not provide a secure fit.The area below the aneurysm is not long enough to support the stent.The inferior mesenteric artery is necessary for your health.You are allergic to certain materials like stainless steel, PTFE, polyester, polypropylene, nitinol, or gold.I cannot take oral antiplatelet medications due to health reasons.I have had a condition where my lymphocytes grow abnormally.I have a history of cancer.My aneurysm is caused by a specific type of aortic damage.My aortic aneurysm has burst or is causing sudden symptoms.My targeted blood vessel is either smaller than 5 mm or larger than 10 mm in diameter.I have an infection that could affect my blood vessels.I am 50 years old or older.I have a blockage in one or both arteries in my lower abdomen that hasn't been treated.I don't have major artery issues that would prevent device implantation.I have a blood clotting disorder that cannot be corrected.You had a severe allergic reaction to contrast dye and cannot take preventive measures.I haven't had cancer in the last 5 years, except for skin cancer.Your body shape makes it difficult to see the aorta clearly on an X-ray.I have a burst blood vessel causing unstable blood pressure.You may need to have an MRI scan within 3 months after receiving the experimental treatment.Your doctor thinks you will live for more than 2 years without any serious blood vessel problems.I have a fungal infection in my artery wall.I have a blockage in my left subclavian artery that hasn't been treated.I have a major surgery planned within 30 days unrelated to my aneurysm treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Main Arm - Physician-modified fenestrated endovascular graft
- Group 2: Expanded Access Arm - Physician-modified fenestrated endovascular graft.
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.
What is the aggregate tally of individuals participating in this experiment?
"Yes, the information on clinicaltrials.gov confirms that this trial is actively seeking participants to join. The study was first published in April 2020 and updated most recently in March 2022 with a goal of enrolling 20 patients from one site."
Answered by AI
Who would meet the criteria to participate in this research investigation?
"This medical trial requires applicants to be between 50 and 95 years of age, with thoracoabdominal aortic aneurysms. The study is admitting 20 patients in total."
Answered by AI
What aims is this trial striving to accomplish?
"The pivotal assessment of this 12-month trial is the 30 day survival rate. Secondary markers being monitored include Conversion to open repair (defined as emergent conversion necessitated by deployment failure/rupture), Paraplegia (complete absence of motor function in one or both legs) and Major Adverse Events."
Answered by AI
Is this clinical research encompassing individuals of advanced age?
"All participants must be within the age range of 50-95. This trial has 7 spots allocated for minors and 150 slots reserved for seniors."
Answered by AI
Are there any available slots for this research scheme?
"Affirmative. Records on clinicaltrials.gov suggest that, since its initial posting of April 22nd 2020, this investigation is currently recruiting volunteers. Specifically, 20 patients are needed from a single medical site."
Answered by AI
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