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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-procedure and 1, 6, 12, 18, and 24 months post procedure
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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My body meets the specific requirements for a medical device placement.
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My aortic aneurysm is at least 5 cm wide or twice the normal size.

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

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

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
1,504 Previous Clinical Trials
4,187,017 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research experiment still enrolling participants?

"Clinicaltrials.gov indicates that this medical trial, posted on July 1st 2012 and revised February 22nd 2022, is not presently looking for participants. However, 153 other trials are currently open to applicants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of Visceral Function Following Endovascular Aortic Aneurysm Repair Using Branched Stent- Grafts
2012. "Evaluation of Visceral Function Following Endovascular Aortic Aneurysm Repair Using Branched Stent- Grafts". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01654133.
All > Abdominal Aortic Aneurysm
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