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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new type of stent graft (a tube to support blood vessels) for individuals with specific aortic aneurysms (bulging in the large artery from the heart). The study consists of two parts: one for thoracoabdominal aneurysms and another for ascending/aortic arch aneurysms. The researchers aim to determine if the branched stent graft can safely improve blood flow and reduce risks associated with these aneurysms. Ideal candidates have aortic aneurysms that are rapidly growing or at risk of bursting, which poses significant danger. Participants should not have severe allergies to the stent materials or other major health concerns that would make surgery risky. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to innovative treatments for 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 prior data suggests that the branched stent graft is safe for endovascular aneurysm repair?

Research has shown that branched stent grafts are generally safe and effective for treating aortic aneurysms. Studies report a high success rate of about 87%, indicating that the procedure usually proceeds as planned. In one study, no deaths related to the aorta occurred, no aneurysms burst, and no patients needed to switch to open surgery. Survival rates were promising, with all patients alive at six months and 93% at one year.

Another study found these grafts safe for both planned and emergency situations. After two years, most patients survived, and very few deaths were related to the aorta. This evidence suggests that branched stent grafts are a reliable option for repairing complex aortic aneurysms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional open surgery for aortic aneurysms, which involves large incisions and significant recovery time, branched stent grafts are introduced via a minimally invasive endovascular approach. This method allows for targeted repair of complex aneurysms, like those in the aortic arch and thoracoabdominal region, with reduced trauma to the body. Researchers are particularly excited because this technique potentially offers a safer and less invasive option, resulting in quicker recovery times and fewer complications compared to standard surgical procedures.

What evidence suggests that this trial's treatments could be effective for aortic aneurysm?

Research has shown that branched stent grafts effectively treat aortic aneurysms. In this trial, participants will join one of two treatment arms: the "Endovascular Ascending/Aortic Arch Branch Repair" arm or the "Endovascular TAAA Repair" arm. One study reported that 86.4% of patients experienced successful treatment, with 90% surviving the early period post-procedure. Another study found all patients alive at six months, with 93.3% surviving at one year. The procedure often reduces aneurysm size, observed in nearly half of the patients. These findings suggest that branched stent grafts offer a promising option for managing complex aortic aneurysms. ^{2 3 6 7 8}

Who Is on the Research Team?

Mark A Farber, MD

Principal Investigator

University of North Carolina, Chapel Hill, NC 27599

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11640084/

Early Experience with Inner Branch Stent–Graft System for ... The clinical success was 86.4%. The perioperative and early freedom from all-cause mortality rates were 90.9% and 90%, respectively. No case of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666250725001725

Outcomes of fenestrated-branched endovascular aortic ... Patient survival was 100% at 6 months and 93.3% ± 16% at 1 year and 3 years. Aneurysm sac reduction >5 mm was observed in 7 (47%) patients. Five (33%) patients ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.068587

Multicenter Study on Physician-Modified Endografts for ... CONCLUSIONS: PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms. Long-term data ...

4. ejves.com ejves.com/article/S1078-5884(24)00341-1/fulltext

Outcomes of Off the Shelf Outer Branched Versus Inner ... This study aimed to compare two commercially available off the shelf branched endografts for thoraco-abdominal aortic aneurysm (TAAA) repair ...

5. jvascsurg.org jvascsurg.org/article/S0741-5214(12)00074-2/fulltext

Efficacy and durability of endovascular thoracoabdominal ... All devices (n = 81) and branches (n = 306) were successfully inserted and deployed, with no conversions to open repair. Overall mortality was 6.2% (n = 5), ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9092505/

Midterm Outcomes for Endovascular Repair of Thoraco- ... Technical success was 87% (39/45), with a non-significant difference between t-Branch and CMD procedures of 89% (25/28) and 82% (14/17), respectively (p = .63).

7. jvascsurg.org jvascsurg.org/article/S0741-5214(23)02175-4/fulltext

Early and midterm outcomes of fenestrated and branched ... Survival was 75.0% (standard error, 4.0%) and freedom from reintervention was 73.3% (standard error, 4.4%) at 36 months. ASA IV and urgent ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31882309/

Outcomes of endovascular repair of chronic postdissection ... At 2 years, there was no difference in patient survival (84% ± 7% vs 72% ± 4%; P = .13), freedom from aorta-related death (98% ± 2 ...