Repair of Thoracoabdominal Aortic Aneurysms

Conditions

• Thoracoabdominal Aneurysm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Medtronic Valiant Thoracoabdominal Stent Graft System — DEVICE
  The Medtronic Valiant Thoracoabdominal Stent Graft System is made up of two main body components and makes use of several off-the-shelf FDA-approved stent graft components The system is comprised of two investigational devices that include the thoracic bifurcation and the visceral manifold. The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal seal for the device. The two limbs of the thoracic bifurcation allows for continued aortic flow while deploying the visceral segment. The visceral manifold is deployed within the larger 20 mm limb of the thoracic bifurcation to set the stage for the visceral debranching. The branches of the visceral manifold extend to the visceral vessel with the use of covered bridging stents and provide distal seal of the manifold.

Study Details

The primary objective of the clinical investigation is to assess the use of the Medtronic Valiant Thoracoabdominal Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.

Key Dates

Start date

Aug 1, 2017

Status verified

Feb 2024

Primary completion

May 31, 2024

Completion

May 31, 2029

Study Design

Enrollment

15 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Primary Study Arm
  Patients meeting primary inclusion/exclusion criteria will be enrolled in this arm and treated with the Medtronic Valiant Thoracoabdominal Stent Graft System.
• Experimental: Expanded Selection Arm
  Patients who fail to meet the inclusion criteria of the Primary Study Arm may be enrolled under the Expanded Selection Arm and be treated with the Medtronic Valiant Thoracoabdominal Stent Graft System.

Primary Outcome Measure

Proportion of subjects free from major adverse events [ Time Frame: 30 days ]

Central Contacts

• Geoffrey Answini, MD
  513-585-1777
  [email protected]
• Darlene Rock
  513-585-1777
  [email protected]

Locations (1)

Find similar trials in Cincinnati, OH

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