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Large Diameter Advantaâ„¢ V12 Covered Stent Trial for Coarctation of the Aorta

NCT00978952 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-07-02

No results posted yet for this study

Summary

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

Conditions

  • Coarctation of the Aorta

Interventions

DEVICE

Large Diameter Advantaâ„¢ V12 Covered Stent

Stent placement

Sponsors & Collaborators

  • Atrium Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Elchanan Bruckheimer, MD · Schneider Children's Medical Center, Israel

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-05-31
Completion
2017-04-30

Countries

  • Australia
  • Brazil
  • Canada
  • Germany
  • Israel
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00978952 on ClinicalTrials.gov