Endovascular Repair for Aortic Aneurysm

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Age <18, Pregnancy, Life expectancy <2 years, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

625 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests special medical devices, either custom-made or pre-made, to fix weakened areas in the main blood vessel (aorta) in patients with specific types of aortic aneurysms. These devices support the weakened sections to prevent them from rupturing. The Zenith platform has been used in various studies for treating complex aortic aneurysms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Endovascular Repair for Aortic Aneurysm?

Research shows that using fenestrated and branched endovascular repair (a less invasive procedure) for complex aortic aneurysms, including those in the thoraco-abdominal area, can be effective. This approach is particularly useful for patients with challenging conditions, as it offers a less invasive alternative to traditional open surgery, which is often associated with higher risks. ^{1 2 3 4 5}

Is endovascular repair for aortic aneurysm generally safe in humans?

The study on thoracic endovascular aortic repair (TEVAR) for aortic conditions suggests that this type of procedure is being used in humans, indicating some level of safety, but specific safety data is not detailed in the provided research. ^{6 7 8 9 10}

How is the endovascular repair for aortic aneurysm different from other treatments?

This treatment is unique because it uses fenestrated and branched endografts, which are custom-made or 'off-the-shelf' devices designed to fit the specific anatomy of a patient's aorta. This approach allows for a less invasive procedure compared to traditional open surgery, making it suitable for high-risk patients with complex aortic aneurysms. ^{1 3 4 5 11}

Eligibility Criteria

This trial is for adults with specific types of aortic aneurysms (bulges in the wall of the artery) that are at risk of rupture and not suitable for standard treatment. Candidates must have anatomy compatible with custom-made or off-the-shelf stent-grafts, be able to follow up, and consent to participate. Pregnant individuals, those with recent procedures or participation in other trials, severe allergies to contrast material, certain infections or connective tissue disorders are excluded.

Inclusion Criteria

I cannot or will not give my consent to participate.

I have a blood clotting disorder that cannot be corrected.

Pregnant, breast-feeding, or planning on becoming pregnant within 60 months

Exclusion Criteria

My aortic dissection does not meet the specific trial criteria.

My aortic arch condition does not meet the specific criteria mentioned.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Endovascular repair using fenestrated and branched devices for complex aortic aneurysms

12 months

Multiple visits for device implantation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Annual visits for monitoring adverse events and device integrity

Extension

Long-term monitoring of participants for major adverse events and device performance

5 years

Treatment Details

Interventions

• Arch cohort
• Endovascular Repair
• Fenestrated CMD
• Type I - III TAAA

Trial Overview The study tests endovascular repair devices on three groups: one using custom devices for juxtarenal/suprarenal/type IV thoracoabdominal aneurysms; another for type I-III thoracoabdominal aneurysms needing branched/fenestrated devices; and a third group treated with patient-specific stent-grafts for aortic arch aneurysms.

Participant Groups

Group I: Type I - III TAAA cohort Experimental Treatment 1 Intervention

Patients enrolled in this arm will be implanted with the custom made/ off-the-shelfp branched devices. The device is aimed to treat type I-III TAAAs.

Group II: Fenestrated CMD cohort Experimental Treatment 1 Intervention

Patients enrolled in this arm will be implanted with the custom made fenestrated device. The device is aimed to treat complex abdominal aortic aneurysms including juxtarenal, suprarenal and type IV thoracoabdominal aneurysms.

Group III: Arch cohort Experimental Treatment 1 Intervention

Patients enrolled in this arm will be implanted with patient-specific stent-grafts with one to three inner branches or a scallop.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Findings from Research

The development of fenestrated and branched endovascular aneurysm repair (F-EVAR, B-EVAR) techniques allows for less invasive treatment options for complex aortic pathologies, which traditionally required more risky open surgeries.

Custom-made endografts tailored to individual patients' anatomy are becoming increasingly important, as they can improve outcomes for challenging cases like thoracoabdominal aortic aneurysms (TAAA), which are associated with high morbidity and mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Aortic Aneurysm: Fenestrated/Branched Endovascular Aortic Repair (EVAR) and Fenestrated/Branched Thoracic Endovascular Aortic Repair (TEVAR). Is Total Endovascular Repair Already Here?] Mehmedovic, A., Konstantinou, N., Jerkku, T., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Emergency Endovascular Repair of Symptomatic Post-dissection Thoraco-abdominal Aneurysm Using a Physician Modified Fenestrated Endograft During the Waiting Period for a Manufactured Endograft. [2022]

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

Results and factors affecting early outcome of fenestrated and/or branched stent grafts for aortic aneurysms: a multicenter prospective study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Early Experience of Endovascular Repair of Post-dissection Aneurysms Involving the Thoraco-abdominal Aorta and the Arch. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Aortic Aneurysm: Fenestrated/Branched Endovascular Aortic Repair (EVAR) and Fenestrated/Branched Thoracic Endovascular Aortic Repair (TEVAR). Is Total Endovascular Repair Already Here?] [2022]

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

Fenestrated and branched endovascular aortic repair for chronic type B aortic dissection with thoracoabdominal aneurysms. [2022]

6. China pubmed.ncbi.nlm.nih.gov

Endovascular repair for retrograde type A intramural hematoma with focal intimal disruption in descending aorta. [2022]

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

Treatment outcome of mineral trioxide aggregate: repair of root perforations-long-term results. [2022]

8. India pubmed.ncbi.nlm.nih.gov

Evaluation of Healing of Periapical Tissue in Permanent Incisors with Open Apices after Unintentional Extrusion of Mineral Trioxide Aggregate - A Retrospective Study. [2022]

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

A nonsurgical endodontic treatment in open-apex and immature teeth affected by dens invaginatus: using a collagen membrane as an apical barrier. [2019]

10. Canada pubmed.ncbi.nlm.nih.gov

Repair of furcal perforation with mineral trioxide aggregate: long-term follow-up of 2 cases. [2008]

11. Germany pubmed.ncbi.nlm.nih.gov

Current results of endovascular repair of thoraco-abdominal aneurysms†. [2014]