Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta|
- Primary Efficacy [ Time Frame: 12 month ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]30 day morbidity rate of Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)
- Secondary Safety [ Time Frame: procedural (time zero) ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||May 2017|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Device: Large Diameter Advanta™ V12 Covered Stent
The performance metric for comparison is based on data from the Congenital Cardiovascular Interventional Study Consortium (CCISC) as reported by Golden and Hellenbrand . 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.
|The Children's Hospital at Westmead|
|Sydney, Australia, 2145|
|Instituto Dante Pazzanese de Cardiologia|
|Sao Paulo, Brazil, 04012-180|
|Hospital for Sick Children Labatt Family Heart Centre|
|Toronto, Ontario, Canada, M5G 1X8|
|Heart Institute Berlin|
|Frankfurt, Germany, 60389|
|Asklepios Klinik Sankt Augustin|
|Sankt Augustin, Germany, 53757|
|Schneider Children's Medical Center|
|Petach Tikva, Israel|
|San Donato Hospital|
|Bristol Royal Hospital for Children and Bristol Royal Infirmary|
|Bristol, United Kingdom, BS2 8BJ|
|Principal Investigator:||Elchanan Bruckheimer, MD||Schneider Children's Medical Center, Israel|