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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
EVOLVE Aorta Trial Summary
This trial will study whether endovascular therapy is effective for treating aortic disease in the ascending aorta, aortic arch, and thoracoabdominal aorta.
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.Check my eligibility
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.See study design
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.
EVOLVE Aorta Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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...
Criterion: Your aorta and its branches need to meet specific size and shape requirements to be eligible for the study.
Select...
I have a large or high-risk aneurysm in my aorta.
Select...
My arteries are suitable for the procedure.
Select...
I need a specific repair for my large or high-risk aneurysm.
Select...
I am at high risk for open surgery on my ascending aneurysm or dissection.
EVOLVE Aorta Trial 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
All-cause mortality
Aneurysm-related death
Stroke and TIA
EVOLVE Aorta 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.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalOTHER
2,918 Previous Clinical Trials
13,192,665 Total Patients Enrolled
Matthew EagletonLead Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled
Matthew J Eagleton, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
401 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a severe allergic reaction to contrast material and cannot receive proper preventive treatment.I have an infection that could risk a graft infection.You are expected to live for more than 2 years.I have a specific type of aneurysm or my aneurysm is at risk of bursting.I can be treated with a standard endovascular prosthesis.I don't have any conditions or allergies that prevent me from having a procedure involving blood vessels.Criterion: Your aorta and its branches need to meet specific size and shape requirements to be eligible for the study.You have allergies to the materials used to make the medical device.Your body shape makes it hard to see your aorta on an X-ray.I have a blood clotting disorder that cannot be corrected.I have a large or high-risk aneurysm in my aorta.I have unstable chest pain.I have a major surgery planned within 30 days after my aneurysm repair.My arteries are suitable for the procedure.I need a specific repair for my large or high-risk aneurysm.I am at high risk for open surgery on my ascending aneurysm or dissection.
Research Study Groups:
This trial has the following groups:- Group 1: Ascending Aortic Arm
- Group 2: Arch Branch Arm
- Group 3: Thoracoabdominal Aortic 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.
Are medical personnel still taking patients for this trial?
"No, this particular trial is not recruiting patients at the moment. The clinical trial was first posted on October 25th 2018 and was last updated February 15th 2022. There are 207 other trials currently looking for candidates however."
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