Endovascular Stent-Graft for Aortic Aneurysm
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen ByWarren J Gasper, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Warren J. Gasper, MD
Disqualifiers: Pregnancy, Serious infection, Coagulopathy, others
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This study is evaluating whether a stent-graft may help treat aortic aneurysms.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Endovascular Branched Stent-Graft, Fenestrated Endovascular Aneurysm Repair (FEVAR), Branched Endovascular Aneurysm Repair (BEVAR), Endovascular Aneurysm Repair (EVAR)?
Research shows that fenestrated and branched endovascular repairs (FEVAR and BEVAR) are effective for treating complex aortic aneurysms, such as those near the kidneys or involving the thoracic aorta. These techniques have been shown to be safe and feasible, with studies reporting positive midterm and long-term outcomes.
12345Is the endovascular stent-graft for aortic aneurysm generally safe for humans?
Research shows that endovascular stent-grafts, including fenestrated and branched types, are generally safe for treating aortic aneurysms, with studies reporting on technical success and manageable risks like acute kidney injury and spinal cord issues. These procedures are considered alternatives to open surgery, especially for complex cases, and have been evaluated for safety and feasibility in various studies.
12467How is the Endovascular Branched Stent-Graft treatment different from other treatments for aortic aneurysms?
The Endovascular Branched Stent-Graft treatment is unique because it uses a minimally invasive approach to repair complex aortic aneurysms by inserting a stent (a small mesh tube) with branches or openings (fenestrations) that allow blood flow to important arteries, unlike traditional open surgery which requires a large incision.
12348Eligibility Criteria
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.Inclusion Criteria
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.
My arteries are suitable for a minimally invasive surgery.
Exclusion Criteria
I have a blood clotting disorder that cannot be corrected.
My aneurysm has burst.
I currently have a serious infection.
Participant Groups
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.
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).
Endovascular Branched Stent-Graft is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Fenestrated Endovascular Aneurysm Repair (FEVAR) for:
- Thoracoabdominal aortic aneurysms (TAAAs)
- Paravisceral abdominal aortic aneurysms (PVAAAs)
🇺🇸 Approved in United States as Branched Endovascular Aneurysm Repair (BEVAR) for:
- Thoracoabdominal aortic aneurysms (TAAAs)
- Paravisceral abdominal aortic aneurysms (PVAAAs)
🇨🇦 Approved in Canada as Endovascular Aneurysm Repair (EVAR) for:
- Abdominal aortic aneurysms (AAAs)
- Thoracoabdominal aortic aneurysms (TAAAs)
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Division of Vascular Surgery, UCSFSan Francisco, CA
Division of Vascular Surgery, SFVAMCSan Francisco, CA
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Who is running the clinical trial?
Warren J. Gasper, MDLead Sponsor
Timothy Chuter, MDLead Sponsor
References
Fenestrated and branched endovascular repair for juxtarenal and thoracoabdominal aortic aneurysms: analysis of the first 100 cases. [2022]Endovascular aortic aneurysm repair (EVAR) has become the most popular technique to treat infrarenal abdominal aortic aneurysms. In aneurysms with unsuitable anatomy open surgical repair remains the golden standard but fenestrated EVAR (FEVAR) or branched EVAR (BEVAR) may be an alternative to treat juxtarenal or thoracoabdominal aneurysms. The aim of this study was to report our results and to evaluate its safety and feasibility.
The Initial Experience on Branched and Fenestrated Endografts in the Aortic Arch. A Systematic Review. [2021]Branched and fenestrated endografts (fEVAR/bEVAR) are complex techniques used to treat thoracic aorta pathologies involving the aortic arch. This systematic review aims to determine all the reported results regarding these techniques in the aortic arch, in order to describe their clinical outcomes.
Midterm Outcomes of BeGraft Stent Grafts Used as Bridging Stents in Fenestrated Endovascular Aortic Aneurysm Repair. [2023]Fenestrated endovascular aneurysm repair (fEVAR) is established for the treatment of juxtarenal, pararenal, and thoracoabdominal aortic aneurysms (TAAAs). Bridging stents are used to connect the main body of the stent graft to the aortic branch vessels. Complications related to the bridging stents compromise the durability of the repair and require urgent re-intervention. Here we present the midterm results of the BeGraft stent graft system used for fEVAR.
Feasibility and Twelve-month Patency of a Six-fold Fenestrated Stent Graft for Type IV Thoracoabdominal Aneurysm Repair. [2020]Fenestrated endovascular aortic aneurysm repair (FEVAR) is a standard procedure for the treatment of complex aortic aneurysm. More than 4 fenestrations are still randomly used, even in case of complex aneurysm anatomy involving accessory renal arteries.
Long-term follow-up of fenestrated endovascular repair for juxtarenal aortic aneurysm. [2018]Fenestrated endovascular aneurysm repair (FEVAR) is increasingly being used for juxtarenal aortic aneurysms. The aim of this study was to review long-term results and assess the importance of changing stent-graft design on outcomes.
Systematic review and meta-analysis on fenestrated or branched devices after previous open surgical aortic aneurysm repair. [2023]Despite open surgical repair (OSR) of abdominal aortic aneurysms being considered as a durable solution, disease progression and para-anastomotic aneurysms may require further repair, and fenestrated and branched endovascular aneurysm repair (F/BEVAR) may be applied to address these pathologies. The aim of this systematic review was to assess technical success, mortality, and morbidity (acute kidney injury, spinal cord ischemia) at 30 days, and mortality and reintervention rates during the available follow-up, in patients managed with F/BEVAR after previous OSR.
Physician-Modified Fenestrated Endografts for Managing the Ruptured or Symptomatic Aortic Aneurysm: Technique Overview and Clinical Outcomes. [2018]Fenestrated endovascular aneurysm repair (FEVAR) grafts have a 10- to 12-week manufacturing time and are generally not available for emergency cases of symptomatic or ruptured aortic aneurysm. In the absence of other alternatives, conventional off-the-shelf stent grafts can be modified by trained operators to treat these complex cases. The aim of this study is to present a single-center experience of physician-modified FEVAR.
Fenestrated and Branched Aortic Grafts. [2018]Abdominal and thoracic aortic aneurysms are diagnosed in 40 and 10 to 15 out of 100 000 persons per year, respectively. Fenestrated (fEVAR) and branched (bEVAR) stent grafts have been developed for abdominal juxtarenal and thoracoabdominal aneurysms. We discuss the patency and complication rates of fEVAR and bEVAR procedures and compare them with the outcome of open surgery.