What is the mechanism of action of this treatment?

Endovascular therapy for Thoracic Aortic Aneurysm involves the insertion of a stent-graft through the blood vessels to reinforce the weakened section of the aorta. This minimally invasive procedure is performed by threading a catheter through the femoral artery to the site of the aneurysm, where the stent-graft is deployed to provide structural support and prevent rupture. This approach is significant for TAA patients as it offers a less invasive alternative to open surgical repair, reducing recovery time, and lowering the risk of complications such as infection and prolonged hospital stays. Additionally, it is particularly beneficial for patients who may not be suitable candidates for open surgery due to comorbid conditions.

What side effects are associated with this type of intervention?

Endovascular therapy, including Thoracic Endovascular Aortic Repair (TEVAR), is a common minimally invasive treatment for Thoracic Aortic Aneurysm. Known side effects of TEVAR include endoleak (persistent blood flow outside the graft but within the aneurysm sac), device migration, stent-graft infolding or collapse, and potential development of aortoesophageal or tracheoesophageal fistulas. Additionally, patients may experience pleural effusions, and there is a risk of fatal complications such as aneurysm rupture or stent-graft erosion into adjacent structures.

What prior FDA approvals exist?

The FDA has approved several endovascular devices for the treatment of Thoracic Aortic Aneurysm (TAA). Notable among these are the Gore TAG Thoracic Endoprosthesis and the Zenith TX2 Endovascular Graft. These devices are used in Thoracic Endovascular Aortic Repair (TEVAR), a minimally invasive procedure that involves placing a stent graft within the aorta to reinforce the weakened section and prevent rupture. Clinical trials and studies have shown that TEVAR can reduce early outcomes such as paraplegia, mortality, and hospital stay compared to conventional open surgical repair.

What other types of research exist?

Promising novel alternatives to endovascular therapy for thoracic aortic aneurysm patients include: 1) Hybrid surgical approaches that combine open surgery with endovascular techniques to optimize outcomes. 2) Advanced imaging and robotic-assisted surgery to enhance precision and reduce recovery times. 3) Development of bioengineered grafts and stents that promote better integration with the body's tissues. 4) Gene therapy and regenerative medicine approaches aimed at strengthening the aortic wall and preventing aneurysm progression. These alternatives are still under investigation but show potential for improved patient outcomes in the near future.

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Endovascular Stent-Graft

Endovascular Stent-Graft for Aortic Disease (EVOLVE Aorta Trial)

N/A

Waitlist Available

Led By Matthew J Eagleton, MD

Research Sponsored by Matthew Eagleton

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Absence of systemic disease or allergy that precludes an endovascular repair

Have ONE of the following: Focal aneurysm in ascending aorta, Pseudoaneurysms and/or dissections distal to the sinotubular junction, A thoracoabdominal aortic aneurysm ≥ 5.0 cm in women and ≥ 5.5 cm in men, Have morphology or growth suggestive of imminent rupture

Must not have

An uncorrectable coagulopathy

Unstable angina

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new, less invasive treatment for patients with serious aortic diseases who cannot undergo regular surgery. The treatment involves placing a supportive device inside the aorta to stop it from growing or rupturing. The study aims to see if this method is safe and effective over time.

Who is the study for?

This trial is for patients with various types of aortic aneurysms and dissections who are at high risk for open surgery. Candidates must have suitable arterial anatomy, no severe allergies to device materials, be able to give informed consent, and comply with follow-up schedules. Pregnant individuals or those with uncorrectable bleeding disorders cannot participate.

What is being tested?

The study tests endovascular stent-graft implantation as a treatment for thoracic aortic disease. It aims to assess the effectiveness of this minimally invasive procedure in repairing diseased sections of the ascending aorta, arch, and thoracoabdominal regions.

What are the potential side effects?

Potential side effects may include complications related to the stent-graft such as movement from its original position, blockage or narrowing of blood vessels (leading to reduced blood flow), puncture-related issues at the access site, allergic reactions to device materials or contrast dye used during imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I don't have any conditions or allergies that prevent me from having a procedure involving blood vessels.

Select...

I have a specific type of aneurysm or my aneurysm is at risk of bursting.

Select...

I am at high risk for open surgery on my ascending aneurysm or dissection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a blood clotting disorder that cannot be corrected.

Select...

I have unstable chest pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

All-cause mortality

Aneurysm-related death

Stroke and TIA

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Thoracoabdominal Aortic ArmExperimental Treatment1 Intervention

Investigational endovascular stent-graft implantation to exclude thoracoabdominal aortic pathology including aortic aneurysms, renal artery aneurysms, and superior mesenteric artery aneurysms.

Group II: Ascending Aortic ArmExperimental Treatment1 Intervention

Investigational endovascular stent-graft implantation to exclude aneurysm or repair dissection of the ascending aorta.

Group III: Arch Branch ArmExperimental Treatment1 Intervention

Investigational endovascular stent-graft implantation to exclude aneurysm or repair dissection of the aortic arch.

0 / 5Eligibility criteria met

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

Endovascular therapy for Thoracic Aortic Aneurysm involves the insertion of a stent-graft through the blood vessels to reinforce the weakened section of the aorta. This minimally invasive procedure is performed by threading a catheter through the femoral artery to the site of the aneurysm, where the stent-graft is deployed to provide structural support and prevent rupture. This approach is significant for TAA patients as it offers a less invasive alternative to open surgical repair, reducing recovery time, and lowering the risk of complications such as infection and prolonged hospital stays. Additionally, it is particularly beneficial for patients who may not be suitable candidates for open surgery due to comorbid conditions.