Clinical Trial: Clinical Outcomes and Radiation Safety After Endovascular Repair of Complex Abdominal Aortic Aneurysms Using CMDs

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Clinical Outcomes and Radiation Safety After Endovascular Repair of Complex Abdominal Aortic Aneurysms Using Custom-Made Devices (CMD)

Brief Summary: This is an investigator sponsored Investigational Device Exemption (IDE) aimed to assess the use of the Custom Made Device (CMD) to repair juxtarenal aneurysms, suprarenal and type IV thoracoabdominal aneurysms in standard risk patients having appropriate anatomy. This study is a prospective, single-center, non-randomized, single-arm study.

Detailed Summary:
Sponsor: University of Texas Southwestern Medical Center

Current Primary Outcome:

  • Primary safety [ Time Frame: 30 days ]
    Primary safety will be defined as the proportion of subjects who experience a major adverse event (MAE) at 30-days or during hospitalization if this exceeds 30 days.
  • Primary effectiveness end-point [ Time Frame: 12 months ]

    For primary effectiveness end-point, treatment success will be analyzed as the proportion of patients to achieve treatment success at 12-months. Treatment success is defined by a composite end-point, which includes all the following criteria described below:

    • Technical success, defined as successful delivery and deployment of the custom-made device with preservation of those branch vessels intended to be preserved.
    • Freedom from type I and III endoleak.
    • Freedom from aortic aneurysm sac enlargement > 5mm.
    • Freedom from endograft migration.
    • Freedom from aortic aneurysm rupture and conversion to open repair.


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of participants with adverse events from the use of bare metal stents as a measure of safety [ Time Frame: 5 years ]

When bare metal balloon expandable or self-expandable stents are required to be used distally to covered stents, target vessel events (kink, stenosis or occlusion) will be analyzed separately at 30 days, 6 months and annually up to five years.


Original Secondary Outcome: Same as current

Information By: University of Texas Southwestern Medical Center

Dates:
Date Received: October 6, 2014
Date Started: December 2014
Date Completion: July 2025
Last Updated: November 25, 2015
Last Verified: November 2015