Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts

Conditions

• Juxtarenal Aortic Aneurysms
• Suprarenal Aortic Aneurysms
• Type IV Thoracoabdominal Aortic Aneurysms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Custom-made Zenith® Fenestrated AAA Endovascular Graft: — DEVICE
  The graft will be inserted through arteries in the groin (called endovascular repair). Endovascular repair is a procedure that uses catheters that go inside your blood vessel to place a stent graft above and below the aneurysm. This procedure lines the aneurysm with a new lining (stent) so blood does not fill the artery any more.

Study Details

The purpose of this study is to evaluate clinical outcomes and quality of life measures in treated by endovascular aortic repair of juxtarenal, suprarenal, and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft.

Key Dates

Start date

Aug 31, 2013

Status verified

Jan 2026

Primary completion

Mar 31, 2025

Completion

May 31, 2030

Study Design

Enrollment

200 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: Endovascular
  The study will include patients treated by endovascular aortic repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft. The graft includes combinations of scallops, 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 be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches. Other names: Endovascular stent Stent-graft

Primary Outcome Measure

Number of subjects who have die at 30 days post treatment [ Time Frame: 30 days post treatment] ]

Central Contacts

• Andrea C Martinez, MS
  713-798-6835
  [email protected]
• Ying Huang, MD, PhD
  832-355-4033
  [email protected]

Locations (2)

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