Endovascular Aneurysm Repair for Aortic Aneurysm

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Age under 18, Pregnancy, Active malignancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

645 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate visceral function, after endovascular repair of thoracoabdominal aneurysms or ascending/aortic arch 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 Branched Stent Graft for Endovascular Aneurysm Repair for Aortic Aneurysm?

Research shows that branched stent grafts are effective in treating complex aortic aneurysms by allowing blood flow to critical arteries while repairing the aneurysm. These devices have been used successfully in various parts of the aorta, with results that compare well to traditional open surgery. ^{1 2 3 4 5}

Is endovascular aneurysm repair generally safe for humans?

Endovascular aneurysm repair, including branched stent grafts, is increasingly used for complex aortic conditions and early experiences have been encouraging, though some intraoperative adverse events have been reported. The long-term safety and durability of these repairs are still being studied, but improvements in technology have made the procedure more widely applicable. ^{2 6 7 8 9}

How does the branched stent graft treatment for aortic aneurysm differ from other treatments?

The branched stent graft treatment for aortic aneurysms is unique because it uses a modular design to maintain blood flow to critical arteries while repairing the aneurysm, which is particularly useful for complex cases involving branch vessels. This approach allows for a more stable fixation and sealing of the graft, overcoming limitations of traditional endovascular repair methods. ^{1 2 5 10 11}

Research Team

Mark A Farber, MD

Principal Investigator

University of North Carolina, Chapel Hill, NC 27599

Eligibility Criteria

This trial is for adults with rapidly growing thoracoabdominal aortic aneurysms, measuring at least 5cm or twice the normal diameter. Candidates must have anatomy suitable for Zenith® p-Branch™ or similar endovascular grafts and be willing to follow the study's schedule. Exclusions include severe contrast allergies, ruptured aneurysms with hypotension, incompatible vessel anatomy, and certain material sensitivities.

Inclusion Criteria

General Inclusion Criteria: Treatment not possible with a currently available non-modified approved device, Patient accepts to and is able to comply with lifetime follow-up, Patient accepts to and is able to provide informed consent prior to enrollment, No stroke with significant residual deficit or myocardial infarction within the last 12 months, No significant carotid bifurcation disease (> 70% stenosis by NASCET criteria), Absence of systemic or local infection that may increase the risk of endovascular graft infection

My aorta is significantly enlarged or has grown quickly, and I may need surgery.

I have a bulging blood vessel that is at risk of bursting.

Exclusion Criteria

Anatomic Exclusion Criteria for the Cook Ascending/Arch graft: Specific anatomical exclusion criteria for the Cook Ascending/Arch graft

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-procedure Evaluation

Detailed CT scan imaging and hemodynamic data collection prior to endovascular repair

1-2 weeks

Treatment

Endovascular repair of thoracoabdominal or aortic arch aneurysms using branched stent grafts

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in renal function and device integrity post-procedure

24 months

Visits at 1, 6, 12, 18, and 24 months post-procedure

Treatment Details

Interventions

• Branched Stent Graft

Trial Overview The study tests how well kidneys and abdominal organs function after repairing thoracoabdominal aortic aneurysms using branched stent grafts like Zenith® p-Branch™. It aims to assess risks of rupture and suitability of patients' anatomies for this minimally invasive procedure.

Participant Groups

Group I: Endovascular TAAA Repair Experimental Treatment 1 Intervention

Endovascular repair of thoracoabdominal aortic aneurysm (TAAA) using Branched stent grafts

Group II: Endovascular Ascending/Aortic Arch Branch Repair Experimental Treatment 1 Intervention

Endovascular repair of aortic ascending/arch aneurysm using branched stent grafts

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

UNC Hospitals

Collaborator

Trials

1

Recruited

650+

Cook Group Incorporated

Industry Sponsor

Trials

92

Recruited

15,500+

Carl Cook

Cook Group Incorporated

Chief Executive Officer since 2011

Bachelor's degree in Engineering from Purdue University, MBA from the University of Iowa

Dr. John A. Kaufman

Cook Group Incorporated

Chief Medical Officer since 2023

MD

Findings from Research

Fenestrated and branched stent grafts have been developed to treat abdominal aortic aneurysms in patients who are not suitable for traditional endovascular repair due to unfavorable anatomy, allowing for a completely endovascular approach.

These advanced stent grafts have shown promising short-term results that are comparable to open surgery, providing a viable option for patients with complex aneurysms and limited surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fenestrated and branched stent grafts. Ricotta, JJ., Oderich, GS.[2016]

In a study of 113 patients undergoing fenestrated and branched stent grafting for complex aortic diseases, intraoperative adverse events (IOAEs) occurred in 30.1% of patients, leading to significant complications in many cases.

Patients who experienced IOAEs had a higher rate of death or moderate to severe complications compared to those without IOAEs, highlighting the need for careful monitoring during these complex procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of intraoperative adverse events during branched and fenestrated aortic stent grafting on postoperative outcome. Cochennec, F., Kobeiter, H., Gohel, MS., et al.[2021]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Branched endovascular stent-graft for suprarenal aortic aneurysm: the future of aortic stent-grafting? [2018]

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

Branched endografts for treatment of complex aortic aneurysms. [2014]

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

Endovascular repair of thoracoabdominal aortic aneurysms using fenestrated and branched endografts. [2019]

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

Fenestrated and branched stent grafts. [2016]

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

Development of a branched stent-graft for endovascular repair of aortic arch aneurysms. [2017]

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

Impact of intraoperative adverse events during branched and fenestrated aortic stent grafting on postoperative outcome. [2021]

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

Incidence, predictive factors, and outcomes of intraprocedure adverse events during fenestrated-branched endovascular aortic repair of complex abdominal and thoracoabdominal aortic aneurysms. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Aortic endograft and bridging stent-graft remodeling after branched endovascular aortic repair. [2021]

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

Aneurysmal degeneration of the aorta after stent-graft repair of acute aortic dissection. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

Fenestrated and branched endovascular techniques for thoraco-abdominal aneurysm repair. [2016]

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

Branched stent-grafts for endovascular repair of aortic and iliac aneurysms. [2006]