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Stent Graft

Endovascular Aneurysm Repair for Aortic Aneurysm

N/A
Waitlist Available
Led By Mark A Farber, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Anatomic Inclusion Criteria: Specific anatomical requirements for device deployment and sealing zones
Aortic Aneurysm Diameter: TAAA (Type I - IV) (including pararenal subtypes) with orthogonal aortic diameter greater than or equal to 5 cm or greater than two times the normal aortic diameter
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-procedure and 1, 6, 12, 18, and 24 months post procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether endovascular repair of thoracoabdominal aneurysms improves visceral function.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions to materials in the stent graft (stainless steel, nitinol), complications from the procedure such as bleeding or infection, kidney damage due to contrast used during imaging studies, and general risks associated with endovascular surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My body meets the specific requirements for a medical device placement.
Select...
My aortic aneurysm is at least 5 cm wide or twice the normal size.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-procedure and 1, 6, 12, 18, and 24 months post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-procedure and 1, 6, 12, 18, and 24 months post procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in renal function over time (up to two years) after endovascular aortic aneurysm repair various custom stent grafts
Secondary study objectives
Branch vessel Events
Endoleak
Time to loss of stent graft integrity
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Endovascular TAAA RepairExperimental Treatment1 Intervention
Endovascular repair of thoracoabdominal aortic aneurysm (TAAA) using Branched stent grafts
Group II: Endovascular Ascending/Aortic Arch Branch RepairExperimental Treatment1 Intervention
Endovascular repair of aortic ascending/arch aneurysm using branched stent grafts

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,554 Previous Clinical Trials
4,292,488 Total Patients Enrolled
UNC HospitalsUNKNOWN
Cook Group IncorporatedIndustry Sponsor
91 Previous Clinical Trials
14,867 Total Patients Enrolled

Media Library

Branched Stent Graft (Stent Graft) Clinical Trial Eligibility Overview. Trial Name: NCT01654133 — N/A
Abdominal Aortic Aneurysm Research Study Groups: Endovascular Ascending/Aortic Arch Branch Repair, Endovascular TAAA Repair
Abdominal Aortic Aneurysm Clinical Trial 2023: Branched Stent Graft Highlights & Side Effects. Trial Name: NCT01654133 — N/A
Branched Stent Graft (Stent Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01654133 — N/A
~202 spots leftby Aug 2030
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