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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 below
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I don't have any conditions or allergies that prevent me from having a procedure involving blood vessels.
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I have a specific type of aneurysm or my aneurysm is at risk of bursting.
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Criterion: Your aorta and its branches need to meet specific size and shape requirements to be eligible for the study.
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I have a large or high-risk aneurysm in my aorta.
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My arteries are suitable for the procedure.
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I need a specific repair for my large or high-risk aneurysm.
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I am at high risk for open surgery on my ascending aneurysm or dissection.

EVOLVE Aorta Trial Timeline

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

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

Endovascular Stent-Graft Implantation (Endovascular Stent-Graft) Clinical Trial Eligibility Overview. Trial Name: NCT00583817 — N/A
Thoracic Aortic Aneurysm Research Study Groups: Ascending Aortic Arm, Arch Branch Arm, Thoracoabdominal Aortic Arm
Thoracic Aortic Aneurysm Clinical Trial 2023: Endovascular Stent-Graft Implantation Highlights & Side Effects. Trial Name: NCT00583817 — N/A
Endovascular Stent-Graft Implantation (Endovascular Stent-Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00583817 — N/A

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."

Answered by AI
~69 spots leftby Dec 2027