Abdominal Aortic Aneurysm (AAA) Clinical Trials

Find Abdominal Aortic Aneurysm (AAA) Clinical Trials Near You

Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal, Thoracoabdominal and Aortic Arch Aneurysms or Dissections With Fenestrated and Branched Stent Grafts

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of fenestrations and/or branches to repair aortic aneurysm.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Thoracoabdominal aortic aneurysm with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter.

• Aneurysm with a history of growth ≥ 0.5 cm per year.

• Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.

• Presence of concomitant thoracoabdominal and aortic arch aneurysm meeting one of the above-mentioned criteria.

• Presence of thoracoabdominal aortic aneurysm meeting one of the above-mentioned criteria with unilateral or bilateral common iliac artery aneurysm with diameter ≥ 3.0-cm or saccular morphology with no suitable landing zone proximal to iliac bifurcation.

Locations
United States
Minnesota
Mayo Clinic
ACTIVE_NOT_RECRUITING
Rochester
Texas
Baylor College of Medicine
RECRUITING
Houston
University of Texas Health Science Center at Houston
ACTIVE_NOT_RECRUITING
Houston
Contact Information
Primary
Andrea C Martinez, MS
andrea.martinez@bcm.edu
713-798-6835
Backup
Ying Huang, MD, PhD
Ying.Huang@bcm.edu
832-355-4033
Time Frame
Start Date: 2014-03
Estimated Completion Date: 2032-05
Participants
Target number of participants: 760
Treatments
Experimental: Complex Abdominal (CAAA) and Thoracoabdominal Aortic Aneurysm (TAAA) Arm
The CAAA and TAAA study arm will include 700 patients treated by endovascular aortic repair of CAAAs and TAAAs (Extent I to IV) using either an off-the-shelf Zenith t-Branch or patient-specific stent-graft with a combination of fenestrations and/or branches, with or without concomitant unilateral or bilateral iliac artery aneurysms treated by iliac branch devices. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches). These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.
Experimental: Aortic Arch Aneurysm Arm
Aortic Arch study arm will include 60 patients with aortic arch aneurysms treated by patient-specific stent-grafts with one to three inner branches or a scallop.~The study will include patients with CAAAs, TAAAs and/or aortic arch aneurysms due to degenerative aneurysms or chronic aortic dissections. The stent-graft design for this study will be individually selected based on anatomy at the discretion of the principal investigator.
Sponsors
Collaborators: William Cook Australia
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov