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A Safety and Effectiveness Study of the MD-12-001 Stent in the Treatment of Superficial Femoral Artery or Popliteal Artery Blockages in Japanese Patients

NCT01746550 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-04-11

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and effectiveness of the MD-12-001 stent in the treatment of superficial femoral artery and proximal popliteal artery blockages in Japanese patients.

Conditions

  • Arterial Occlusive Disease

Interventions

DEVICE

MD-12-001 Stent

MD-12-001 is a self-expanding nitinol stent

Sponsors & Collaborators

  • Medicon, Inc.

    collaborator INDUSTRY

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Masato Nakamura · Toho University Ohashi Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-10-11
Completion
2018-10-31

Countries

  • 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 NCT01746550 on ClinicalTrials.gov