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Stent Graft
Stent-Graft for Aortic Aneurysm (IDE#2 Trial)
N/A
Recruiting
Led By Gustavo S. Oderich, MD FACS
Research Sponsored by Gustavo S. Oderich
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
In the setting of more distal disease: The repair may be coupled with a thoracoabdominal branched device, infrarenal device, and/or internal iliac branch device
Iliac anatomy must allow for the delivery of the arch branch device which is loaded within a 20F-24F sheath. Thus the iliac requirements are no different than the standard thoracic protocol. Conduits to the iliac vessels or aorta may be used if deemed necessary
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post treatment
Awards & highlights
IDE#2 Trial Summary
This trial is testing a new type of stent-graft to see if it is safe and effective in repairing aortic aneurysm.
Who is the study for?
Adults with specific aortic aneurysms or dissections who are not pregnant, breastfeeding, or have a life expectancy under 2 years. They must be willing to follow the trial schedule and give consent. Exclusions include recent surgeries unrelated to the condition, participation in certain other trials, allergies to device materials, uncorrectable coagulopathy, active infections, certain connective tissue disorders.Check my eligibility
What is being tested?
The Zenith t-Branch and customized stent-graft systems are being tested for safety and effectiveness in repairing complex aortic aneurysms. These devices use fenestrations/branches designed for each patient's unique anatomy.See study design
What are the potential side effects?
Potential side effects may include reactions to device materials (stainless steel, nitinol), complications from implantation like bleeding or infection, allergic reactions to contrast material used during surgery if pre-medication is insufficient.
IDE#2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My treatment may include a specific device for my lower torso condition.
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My body can accommodate a specific device for my heart surgery.
Select...
I have an aneurysm in both my chest and upper stomach area.
Select...
My aorta fits the required size and position for the procedure.
Select...
My aneurysm has grown at least 0.5 cm in a year.
Select...
My aorta or graft is 20-42mm wide with a neck length of at least 20mm.
Select...
I am eligible for a customized vascular graft procedure.
Select...
My aortic dissection can be accessed and treated with a stent through my groin.
Select...
My aorta is enlarged, measuring 5.5 cm or more, or twice its normal size.
Select...
My doctor thinks my aneurysm is at high risk of bursting.
Select...
I have a large aneurysm in my chest or abdomen and in the arteries to my legs.
IDE#2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post treatment
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 who experience a Major Adverse Event at 30 days post treatment
Number of subjects who have died at 30 days post treatment
Secondary outcome measures
Mean Quality of Life Measure at Various Time Points
Percentage of subjects who achieve treatment success
IDE#2 Trial Design
2Treatment groups
Experimental Treatment
Group I: Thoracoabdominal Aortic Aneurysm ArmExperimental Treatment1 Intervention
The TAAA study arm will include patients treated by endovascular aortic repair of thoracoabdominal aortic aneurysms (Extent I to IV) using either an off-the-shelf Zenith t-Branch or patient-specific stent-graft with a combination of fenestrations and/or branches. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches) . These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.
Group II: Aortic Arch Aneurysm ArmExperimental Treatment1 Intervention
Aortic Arch study arm will include patients with aortic arch aneurysms treated by Patient-specific stent-grafts with one to three inner branches or a scallop. The study will include patients with thoracoabdominal and/or aortic arch aneurysms due to degenerative aneurysms or chronic aortic dissections. The stent-graft design for this study will be individually selected based on anatomy at the discretion of the principal investigator, including an off-the-shelf stent-graft (t-Branch stent-graft) or patient-specific stent-graft with a combination of fenestrations and/or branches.
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Who is running the clinical trial?
Gustavo S. OderichLead Sponsor
Gustavo OderichLead Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
William Cook AustraliaIndustry Sponsor
4 Previous Clinical Trials
674 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My treatment may include a specific device for my lower torso condition.My body can accommodate a specific device for my heart surgery.I have an aneurysm in both my chest and upper stomach area.You are expected to live for less than 2 years.I need urgent repair for a ruptured aortic aneurysm, but it's stable and fits standard treatment designs.You are not participating in any other experimental medical or device trials, except for specific trials related to endovascular stent-grafts or other approved medical therapies to reduce risks during fenestrated-branched endovascular repair.I cannot have surgery for a pathway in my hip area due to access issues.I have a leaking or ruptured aneurysm with low blood pressure.My aorta fits the required size and position for the procedure.You had a severe allergic reaction to contrast material in the past, and pre-medication won't help prevent it.I haven't had major surgery in the last 30 days, except for specific ones to prepare for a vascular repair.My blood vessels are not suitable for a specific stent due to blockage or size.My iliac artery is not suitable for certain surgical procedures due to its size or condition.My aneurysm has grown at least 0.5 cm in a year.I cannot or will not give my consent to participate.I have a fungal infection in my artery or an active infection throughout my body.I have a connective tissue disorder but it doesn't affect my blood vessels.My aorta or graft is 20-42mm wide with a neck length of at least 20mm.I am eligible for a customized vascular graft procedure.My aortic dissection can be accessed and treated with a stent through my groin.You have allergies to certain materials like stainless steel, polyester, or gold.I am under 18 years old.My aorta is enlarged, measuring 5.5 cm or more, or twice its normal size.I have a blood clotting disorder that cannot be corrected.My doctor thinks my aneurysm is at high risk of bursting.Your body shape makes it difficult to see your aorta and its branches on an X-ray.I have a large aneurysm in my chest or abdomen and in the arteries to my legs.My veins are too small for the needed medical equipment.My aorta is the right size and shape for the procedure, without major calcium deposits or clots.
Research Study Groups:
This trial has the following groups:- Group 1: Thoracoabdominal Aortic Aneurysm Arm
- Group 2: Aortic Arch Aneurysm 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.
How many participants are being admitted to this experiment?
"Indeed, the data on clinicaltrials.gov shows that this research endeavour is actively seeking patients to join in. The trial was initially announced on March 1st 2014 and has subsequently been updated as recently as October 31st 2022. 530 individuals are being sought at a single medical site for participation in the study."
Answered by AI
Are there any open slots available for those interested in participating in this experiment?
"Clinicaltrials.gov verifies that this medical research is still open to enrolment, having been initially posted on March 1st 2014 and recently updated on October 31st 2022."
Answered by AI
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