Endovascular Aneurysm Repair for Aortic Aneurysm

Overseen by Mark A Farber, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of North Carolina, Chapel Hill

No Placebo Group

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.

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

General Exclusion Criteria: Life expectancy less than 2 years, Less than 18 years of age, Women must not be pregnant or breastfeeding, Active malignancy with life expectancy less than 2 years, Presence of mycotic aneurysm, systemic or local infection in access sites that may increase the risk of endovascular graft infection, Untreatable coagulopathy, Coronaropathy / Unstable angina, Anaphylactic reaction to contrast that cannot be adequately pre-medicated, Cultural objection to receipt of blood or blood products, Allergy or sensitivity to the endografts material, Leaking or ruptured aneurysm associated with hypotension, Participation in another investigational clinical or device trial within specific exceptions, Prior open surgical or interventional procedure within 30 days of the anticipated date of the fenestrated-branched procedure with specific exceptions

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

Treatment Details

Interventions

• Branched Stent Graft (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+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

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