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Evaluation of the Vascutek Hybrid Graft for Use in the Replacement of the Aortic Arch and Concomitant Treatment of an Aneurysm/Dissection of the Descending Aorta in the Frozen Elephant Trunk Procedure

NCT01541410 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2013-07-15

No results posted yet for this study

Summary

The purpose of this feasibility study is to investigate the clinical performance of the Vascutek Hybrid Device in the treatment of subjects with aneurysm and/or dissection of the thoracic aorta.

Conditions

  • Aneurysmal Disease of the Ascending Aorta, the Arch and the Proximal Descending Aorta

Interventions

DEVICE

Vascutek Hybrid Graft

Single Group Assignment

Sponsors & Collaborators

  • Vascutek Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
29 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-08-31

Countries

  • Germany

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 NCT01541410 on ClinicalTrials.gov