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Stent-Graft
Endovascular Stent-Graft for Aortic Aneurysm
N/A
Recruiting
Led By Warren J Gasper, MD
Research Sponsored by Timothy Chuter, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aortic aneurysms: greater than or equal to 6 cm in diameter in men
Aortic aneurysms: greater than or equal to 5.5 cm in diameter in women
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing a new way to treat thoracoabdominal and paravisceral abdominal aortic aneurysms by placing a stent-graft over the aneurysm.
Who is the study for?
This trial is for men and women with large aortic aneurysms (5.5 cm or more in diameter for women, 6 cm or more for men) including those that are growing quickly or have associated iliac aneurysms. Participants should expect to live at least two years, be able to consent, follow the study plan, and have suitable anatomy for the procedure. Pregnant individuals, those allergic to certain metals or materials used in stents, with uncontrolled bleeding disorders or serious infections cannot join.Check my eligibility
What is being tested?
The trial tests a new endovascular treatment using a branched stent-graft placed over thoracoabdominal and paravisceral abdominal aortic aneurysms. It aims to evaluate how safe and effective this minimally invasive operation is compared to traditional surgery.See study design
What are the potential side effects?
Potential side effects may include complications related to the placement of the stent such as blood vessel damage, infection risk at the insertion site, allergic reactions to stent materials like Nitinol or polyester, clotting issues around the graft area leading possibly leading to further interventions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man with an aortic aneurysm 6 cm or larger.
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My aortic aneurysm is at least 5.5 cm wide.
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My aortic aneurysm is larger than 5 cm and growing quickly.
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I have an iliac aneurysm larger than 4 cm.
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My arteries are suitable for a minimally invasive surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Successful implantation of TAAA branched stent-graft.
Secondary outcome measures
Long term success of TAAA branched stent-graft treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionalExperimental Treatment1 Intervention
Endovascular Branched Stent-Graft: The investigational operation is done making small incisions in both groins and the right arm and placing a graft in the aorta through tubes that are inserted through the femoral and brachial arteries, than fastening it in position with metal springs(stents).
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatment for Thoracoabdominal Aortic Aneurysms (TAAA) is endovascular stent-grafting. This procedure involves placing a stent-graft within the aorta to reinforce the vessel wall and prevent aneurysm rupture.
The stent-graft acts as a scaffold, providing structural support to the weakened area of the aorta, thereby reducing the risk of rupture. This is crucial for TAAA patients because the aneurysm's location involves critical arteries supplying blood to major organs.
By reinforcing the aorta, the stent-graft helps maintain blood flow and reduces the likelihood of life-threatening complications.
Treatment of thoracoabdominal aortic aneurysms with a combined endovascular and surgical approach.Impact of endovascular repair on open aortic aneurysm surgical training.
Treatment of thoracoabdominal aortic aneurysms with a combined endovascular and surgical approach.Impact of endovascular repair on open aortic aneurysm surgical training.
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Who is running the clinical trial?
Timothy Chuter, MDLead Sponsor
1 Previous Clinical Trials
25 Total Patients Enrolled
Warren J Gasper, MDPrincipal InvestigatorUniversity of California, San Francisco
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a blood clotting disorder that cannot be corrected.I am a man with an aortic aneurysm 6 cm or larger.My aortic aneurysm is at least 5.5 cm wide.My aortic aneurysm is larger than 5 cm and growing quickly.I have an iliac aneurysm larger than 4 cm.You are expected to live for at least 2 more years.The expected risk of death is similar to what is seen with regular surgery.My arteries are suitable for a minimally invasive surgery.My aneurysm has burst.I currently have a serious infection.
Research Study Groups:
This trial has the following groups:- Group 1: Interventional
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.
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