Endovascular Stent-Graft for Aortic Disease
(EVOLVE Aorta Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called an endovascular stent-graft for certain types of aortic disease. It focuses on conditions like aneurysms (bulges in the blood vessels) or dissections (tears in the vessel wall) in various parts of the aorta, the body’s main artery. The trial has three main parts, each testing the stent-graft on a different section of the aorta: the ascending aorta, the aortic arch, and the thoracoabdominal segment. People with these conditions who cannot easily undergo open surgery might be suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to innovative research that could lead to new treatment options.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
What prior data suggests that endovascular stent-graft implantation is safe for treating aortic disease?
Research has shown that using endovascular stent-grafts to treat aortic disease is generally safe and effective in various parts of the aorta.
For the ascending aorta, studies have demonstrated good results. Specifically, more than 88% of patients remained well two years after treatment, indicating the procedure's safety for many individuals.
In the aortic arch, the procedure succeeded in over 97% of cases, meaning it was performed correctly and worked well for most patients, suggesting it is a reliable and safe option.
For the thoracoabdominal aorta, this treatment serves as a less invasive alternative to traditional surgery, potentially offering a safer and easier recovery for patients. Studies show that this method is gaining popularity due to its safety and effectiveness.
Overall, evidence supports that endovascular stent-graft treatments are safe and effective for aortic disease, with high success rates and positive patient outcomes.12345Why are researchers excited about this trial?
Researchers are excited about endovascular stent-graft implantation for aortic disease because it offers a minimally invasive alternative to traditional open surgery. Unlike conventional methods that require large incisions and longer recovery times, this treatment uses a catheter to place a stent-graft inside the aorta, which can reduce hospital stays and improve recovery speed. Additionally, this approach allows for the precise targeting of aneurysms or dissections in difficult-to-reach areas like the ascending aorta, aortic arch, and thoracoabdominal aorta, potentially leading to better outcomes and fewer complications.
What evidence suggests that endovascular stent-graft implantation is effective for aortic disease?
This trial will evaluate the effectiveness of endovascular stent-grafts for treating various aortic diseases. Participants in the Ascending Aortic Arm will receive the investigational stent-graft for conditions in the ascending aorta. Research has shown that this procedure succeeded in all patients, with an overall 5-year survival rate of 80.9%, suggesting it could be a viable option for high-risk patients. In the Arch Branch Arm, the procedure targets diseases of the aortic arch and succeeds about 97.4% of the time, with few complications. Participants in the Thoracoabdominal Aortic Arm will receive treatment for conditions affecting the thoracoabdominal aorta, which helps maintain blood flow to vital organs and stops blood flow to aneurysms. These findings highlight the potential benefits of endovascular stent-grafts in managing complex aortic diseases.13678
Who Is on the Research Team?
Matthew Eagleton, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Endovascular therapy is provided to patients with aortic pathology, including aneurysm, pseudoaneurysm, and/or dissection, using investigational endovascular stent-graft implantation.
Follow-up
Participants are monitored for safety, efficacy, and rupture-free survival, with primary outcomes including freedom from peri-operative neurologic events and aneurysm-related death.
Long-term Follow-up
Long-term monitoring for safety, durability, and rupture-free survival of the endovascular repair.
What Are the Treatments Tested in This Trial?
Interventions
- Endovascular Stent-Graft Implantation
Trial Overview
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.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Investigational endovascular stent-graft implantation to exclude thoracoabdominal aortic pathology including aortic aneurysms, renal artery aneurysms, and superior mesenteric artery aneurysms.
Investigational endovascular stent-graft implantation to exclude aneurysm or repair dissection of the ascending aorta.
Investigational endovascular stent-graft implantation to exclude aneurysm or repair dissection of the aortic arch.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Matthew Eagleton
Lead Sponsor
Massachusetts General Hospital
Collaborator
Citations
Outcomes of thoracic endovascular aortic repair with ...
The approach demonstrates favorable branch patency, a low complication rate, and minimal postoperative mortality. Keywords: Aortic arch pathologies; Partial ...
Safety and Efficacy of Inner Branched Stent-Graft in the ...
Pooled mean technical success rate was 97.4±4.4% (95% confidence interval [CI]=95.1%-99.5%); 2 and 3 patients required conversion to chimney ...
3.
advradiology.org
advradiology.org/articles/thoracic-endovascular-stent-graft-implantation-efficacy/AdvRadiolImaging.galenos.2024.47966Thoracic Endovascular Stent Graft Implantation Efficacy
While the mortality rate in patients with ruptured aneurysms was 75% (3/4), this rate was 7% (1/14) in those with acute dissection. No mortality ...
Outcomes of thoracic endovascular aortic repair with ...
In 2022, Dueppers et al reported their experience with 33 parallel stent grafts, with mortality, stroke, endoleak and technical success rates of 18%, 6%, 43% ...
Aortic Arch Reconstruction by Transluminally Placed ...
The present report demonstrates that endovascular grafting with this branched stent graft device has acceptable clinical results for the treatment of aortic ...
Outcomes of a Novel Single-Branched Aortic Stent Graft for ...
Device technical success and procedural success were achieved in 129 of 132 (97.7%) and 110 of 132 (83.3%) patients, respectively, and there was 1 instance of ...
Endovascular stent–graft placement in aortic dissection
The survival rates were 93.3±1.4% at 30 days, 90.6±1.6% at 6 months, 89.9±1.7% at 1 year, and 88.8±1.9% at 2 years, respectively. Results of stent–graft ...
8.
bmccardiovascdisord.biomedcentral.com
bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-023-03494-3Feasibility and safety of Stanford A aortic dissection complete ...
The acute procedure success rate was 100% (3/3). The immediate post-procedural angiography showed that both type A SGs and type C SGs were ...
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