Clinical Trial: Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta

Brief Summary: This study is designed as a prospective, multicenter, non-randomized, single arm study to assess the safety and effectiveness of the Large Diameter Advanta™ V12 Covered Stent for stent implantation in coarctations of the aorta.

Detailed Summary:

The performance metric for comparison is based on data from the Congenital Cardiovascular Interventional Study Consortium (CCISC) as reported by Golden and Hellenbrand [1]. The CCISC experience from 1989 to 2005 shows a true procedural success rate of 98.6%.

The patient population will be subjects with coarctation of the aorta. A total of 70 subjects, children, adolescents and adults, will be enrolled at up to 15 study sites. Baseline clinical and angiographic assessment will determine the subject's eligibility for enrollment in the study. Subjects will continue in the study for long term annual follow-up through 3, 4, and 5 years.


Sponsor: Atrium Medical Corporation

Current Primary Outcome:

  • Primary Efficacy [ Time Frame: 12 month ]
    The mean difference between Diastolic Velocity (DV)/Systolic Velocity(SV) pre and post procedure (i.e. pre procedure DV/SV - post procedure DV/SV) minus the difference between 12 month and post procedure (i.e. 12 month DV/SV - post procedure DV/SV).
  • Primary Safety [ Time Frame: 30 days of procedure ]
    30 day morbidity rate of Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)


Original Primary Outcome: A significant reduction in the gradient across the coarctation as assessed pre stent versus immediately post stent and pre stent versus 12 month follow-up in two values from the Doppler echocardiographic profile: DV and DV/SV. [ Time Frame: 12 months ]

Current Secondary Outcome:

  • Secondary Safety [ Time Frame: procedural (time zero) ]
    Device success, defined as the successful delivery and deployment of the study stent and intact retrieval of the delivery system.
  • Secondary Safety [ Time Frame: 12 month ]
    No post procedural stent migration, where migration is defined as displacement of the stent >20mm from an established anatomical landmark verified during deployment.
  • Secondary Safety [ Time Frame: 12 months ]
    Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)


Original Secondary Outcome:

  • Device success, defined as the successful delivery and deployment of the study stent and intact retrieval of the delivery system. [ Time Frame: procedural (time zero) ]
  • No post procedural stent migration, where migration is defined as displacement of the stent >20mm from an established anatomical landmark verified during deployment. [ Time Frame: 12 month ]
  • MAE and MAVE [ Time Frame: 12 months ]


Information By: Atrium Medical Corporation

Dates:
Date Received: September 14, 2009
Date Started: September 2009
Date Completion: May 2017
Last Updated: June 8, 2016
Last Verified: June 2016