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Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis

NCT02568293 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2017-02-09

No results posted yet for this study

Summary

The purpose of this study is to compare balloon angioplasty plus SBCV against balloon angioplasty alone for treatment of stenosis within the femoropopliteal artery.

Conditions

  • Peripheral Arterial Disease

Interventions

OTHER

SBCV

SBCV is a single use, sterile product that acts as a localized physical barrier at the vascular wall.

OTHER

Saline

Saline is used as a control.

Sponsors & Collaborators

  • Symic Biomedical, Inc.

    collaborator INDUSTRY

  • Symic Vascular

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-09-30
Completion
2017-10-31

Countries

  • Australia
  • New Zealand

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 NCT02568293 on ClinicalTrials.gov