NCT00978952

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Atrium Medical Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Coarctation of the Aorta

Interventions

Type	Name	Description
DEVICE	Large Diameter Advanta™ V12 Covered Stent	Stent placement

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-05-01
• Completion: 2017-04-01
• First posted: 2009-09-17
• Last updated: 2017-07-02

Locations

9 sites across 7 countries: Australia, Brazil, Canada, Germany, Israel, Italy, United Kingdom