Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices

Conditions

• Aortic Arch Aneurysm
• Complex Aortic Aneurysms
• Ehlers-Danlos Syndrome
• Juxtarenal Aneurysms
• Loeys-Dietz Syndrome
• Marfan Syndrome
• Pararenal Aneurysms
• Thoracoabdominal Aneurysms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Custom Made Fenestrated or Branched Stent Graft — DEVICE
  The surgeon will place a custom made graft, t-Branch device or modify commercially available stent grafts to match the anatomy of the patient being treated. Small fenestrations (holes) will be made in the stent graft so that additional stents can be inserted through the fenestration and into the blood vessels that lead to the kidneys, intestines or liver. These stents allow blood to flow freely to these organs. If the aneurysm is in the aortic arch stents may be placed in the carotid and subclavian arteries. This surgery is done through small incisions in the groin and sometimes in the upper arm.

Study Details

The purpose of this study is to evaluate the safety and efficacy of custom made devices, Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms, thoracoabdominal aneurysms and aortic arch aneurysms who (1) have anatomy not suitable for endovascular repair using grafts currently marketed in the United States,(2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair. Amendment to the study has created a cohort open to people with connective tissue diseases such as Marfan, Ehlers-Danlos or Loey-Dietz syndromes to enroll in the trial. An additional amendment to the study allows the use of a custom made device to treat an aneurysm in the aortic arch.

Key Dates

Start date

Mar 31, 2014

Status verified

Oct 2025

Primary completion

Mar 31, 2030

Completion

Mar 31, 2030

Study Design

Enrollment

600 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Endovascular repair
  Endovascular repair of Complex Aortic Aneurysm using a physician modified stent graft. custom made device or arch branch device.

Primary Outcome Measure

The effectiveness of physician modified endovascular grafts will be determined by evaluating the proportion of patients that achieve Treatment Success [ Time Frame: 12 months post procedure ]

Central Contacts

• Shauneen Valliere, MSN, NP
  508-856-1767
  [email protected]
• Andres Schanzer, MD
  508-856-5599
  [email protected]

Locations (1)

Find similar trials in Worcester, MA

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