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The PROTEMBO SF Trial

NCT03325283 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-10-31

No results posted yet for this study

Summary

The PROTEMBO SF Trial is a prospective, observational, multi-center, intention-to-treat study of the safety and feasibility of the ProtEmbo Cerebral Protection System in subjects with severe symptomatic native aortic valve stenosis indicated for TAVR.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

ProtEmbo Cerebral Protection System

A catheter-based embolic deflection device will be positioned in the arch of the aorta to prevent debris liberated during the TAVR procedure from entering the three major vessels of the aortic arch.

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • Protembis GmbH

    lead INDUSTRY

Principal Investigators

  • James C. Leiter, M.D. · Avania

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-09
Primary Completion
2018-08-31
Completion
2018-10-30

Countries

  • Ireland
  • Latvia

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 NCT03325283 on ClinicalTrials.gov