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Angioshield First-In-Human Study to Demonstrate the Preliminary Safety and Efficacy

NCT02072239 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-01-13

No results posted yet for this study

Summary

The purpose of this study is to determine whether or not the Angioshield device can be safely applied to support saphenous vein grafts used in standard coronary bypass surgery.

Conditions

Interventions

DEVICE

Angioshield

The Angioshield wrap provides external structural support for the saphenous vein graft used in CABG surgery and is intended to prevent over distention of the graft under arterial pressure, potentially improving graft patency and reducing the likelihood of graft failure.

Sponsors & Collaborators

  • Neograft Technologies, Incorporated

    lead INDUSTRY

Principal Investigators

  • Jerzy Sadowski, MD, PhD · Pope John Paul II Hospital and Cardiology Collegium Medicum Jagiellonian University, Krakow, Poland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-09-30
Completion
2015-07-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

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 NCT02072239 on ClinicalTrials.gov