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Use of the GARDEX™ Embolic Protection Device During Percutaneous Coronary Interventions of Saphenous Vein Graft

NCT01042444 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-01-03

No results posted yet for this study

Summary

This is a multi center, prospective study designed to demonstrate the safety and performance of the GARDEX Embolic Protection System when used as an adjunctive device during saphenous vein graft (SVG) interventions.

Conditions

  • Saphenous Vein Graft Disease
  • Myocardial Ischemia
  • Embolism

Interventions

DEVICE

GARDEX™

GARDEX is an embolic protection system to contain and remove embolic material (thrombus/debris) during cardiovascular interventions. The diameter of the vessel at the site of filter basket placement should be between 3.5 mm to 6.0 mm. The GARDEX Embolic Protection System may be used with commercially available 0.014" guide wires.

Sponsors & Collaborators

  • Gardia Medical

    lead INDUSTRY

Principal Investigators

  • Uri Rosenschein, MD · Bnei Zion Hospital, Haifa Israel

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Israel

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 NCT01042444 on ClinicalTrials.gov