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Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis

NCT01475799 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2016-11-01

No results posted yet for this study

Summary

The purpose of the study is to determine the safety and performance of the Direct Flow Medical study valve and delivery procedure.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Replacement of the Aortic Stenotic Valve

Treatment for patients with Severe Aortic Stenosis.

Sponsors & Collaborators

  • Direct Flow Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Thierry LeFevre, M.D. · Study PI

  • Prof. Joachim Schofer · Study PI

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-07-31
Completion
2019-07-31

Countries

  • France
  • Germany
  • Italy
  • Luxembourg
  • 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 NCT01475799 on ClinicalTrials.gov