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Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System

NCT02400905 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2021-06-04

Study results available
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Summary

To demonstrate that the BioMimics 3D Stent System meets the performance goals defined by VIVA Physicians, Inc. for the safety and effectiveness of Nitinol stents used in the treatment of symptomatic disease of the femoropopliteal artery. It is a prospective, single-arm, multicenter clinical trial.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

BioMimics 3D Vascular Stent System

Femoropopliteal stenting

Sponsors & Collaborators

  • ClinLogix. LLC

    collaborator INDUSTRY

  • Yale Cardiovascular Research Group

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Veryan Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Timothy M. Sullivan, MD · Minneapolis Heart Institute / Abbott Northwestern Hospital

  • Thomas Zeller, MD · Herz-Zentrum University Hospital

  • Masato Nakamura, MD · Toho University Ohashi Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-29
Primary Completion
2017-11-03
Completion
2019-12-03

Countries

  • United States
  • Germany
  • Japan

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 NCT02400905 on ClinicalTrials.gov