Endovascular Stent-Graft for Aortic Disease

(EVOLVE Aorta Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Matthew Eagleton

Disqualifiers: Pregnancy, Unstable angina, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

170 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Endovascular Stent-Graft Implantation for aortic disease?

Research shows that endovascular stent-grafts are effective in treating aortic aneurysms (bulging in the aorta) and other aortic emergencies, with studies highlighting their clinical value and positive long-term outcomes. ^{1 2 3 4 5}

Is the endovascular stent-graft generally safe for humans?

Endovascular stent-grafts have been associated with some complications, such as endoleaks (leakage around the graft), graft thrombosis (blood clot in the graft), and graft kinking (bending of the graft). While these complications can be serious, understanding and recognizing them can help ensure a safer procedure. ^{1 6 7 8 9}

How is endovascular stent-graft implantation different from other treatments for aortic disease?

Endovascular stent-graft implantation is a less invasive alternative to open surgery for treating aortic aneurysms and dissections, as it involves placing a stent (a small mesh tube) inside the blood vessel through a small incision, rather than opening the chest or abdomen. This approach can reduce recovery time and complications associated with traditional surgery. ^{1 2 7 10 11}

Research Team

Matthew Eagleton, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

You are expected to live for more than 2 years.

Capable of giving informed consent and willingness to comply with follow up schedule

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

Exclusion 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.

I can be treated with a standard endovascular prosthesis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Endovascular therapy is provided to patients with aortic pathology, including aneurysm, pseudoaneurysm, and/or dissection, using investigational endovascular stent-graft implantation.

4-6 weeks

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.

5 years

Long-term Follow-up

Long-term monitoring for safety, durability, and rupture-free survival of the endovascular repair.

5 years

Treatment Details

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.

Participant Groups

Group I: Thoracoabdominal Aortic Arm Experimental Treatment 1 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 Arm Experimental Treatment 1 Intervention

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

Group III: Arch Branch Arm Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Matthew Eagleton

Lead Sponsor

Trials

2

Recruited

190+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

References

1. China pubmed.ncbi.nlm.nih.gov

[Treatment of the infrequent complications after stent graft placement for aortic disease]. [2005]

2. China pubmed.ncbi.nlm.nih.gov

[Endoluminal stent-graft repair of aortic aneurysms]. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Long-term follow-up after endovascular treatment of acute aortic emergencies. [2008]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Endovascular repair for thoracic aortic pathologies--early and midterm results. [2016]

5. China pubmed.ncbi.nlm.nih.gov

[Endoluminal stent-graft for aortic aneurysms: a report of six cases]. [2013]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Thoracic Endovascular Aortic Repair Adverse Events Reported In The Food And Drug Administration Manufacturer And User Facility Device Experience Database. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Complications of endovascular repair for thoracic and abdominal aortic aneurysm: an imaging spectrum. [2016]

8. Germany pubmed.ncbi.nlm.nih.gov

[Emergency endovascular treatment of acute aortic diseases]. [2016]

9. England pubmed.ncbi.nlm.nih.gov

The evolving technique of endovascular stenting of abdominal aortic aneurysm; time for reappraisal. [2004]

10. United States pubmed.ncbi.nlm.nih.gov

Midterm results of stent-graft repair of acute and chronic aortic dissection with descending tear: the complication-specific approach. [2022]

11. Australia pubmed.ncbi.nlm.nih.gov

Endoluminal stent grafts for aortic diseases: experience at a major teaching hospital in Hong Kong. [2019]