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Not Yet RecruitingPhase 1ACTRN12605000277640

Physician Preference/ Performance Evaluation of F.A.S.T.-LVG for the Temporary Occlusion of Blood Flow in Patients During Interventional Procedures in Saphenous Vein Grafts and Coronary Arteries

Sponsor

Genesis Medical Interventional, Inc.

Enrollment

60 participants

Start Date

Sep 1, 2005

Study Type

Interventional

Conditions

Prevention/reduction of release or movement of potentially embolic debris from the treatment area and aspiration of such debris prior to blood flow restoration.

Summary

Physician satisfaction with device performance in preventing blood clots/debris from traveling from treatment site to the heart or head.

Eligibility

Sex: Both males and femalesMin Age: 21 Yearss

Inclusion Criteria1

  • Patient with evidence of myocardial ischemia; with 50-100% stenosed coronary or SVG; with target vessel 2.5-5.5 mm; with 2 cm vessel proximal to lesion; with only one vessel requiring treatment, with adquate renal function; no angioplasty or stenting within past 24 hrs.

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Interventions

Temporary proximal occlusion of saphenous vein grafts and coronary arteries during standard intervetional procedures.

Temporary proximal occlusion of saphenous vein grafts and coronary arteries during standard intervetional procedures.

Locations(1)

United States of America

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ACTRN12605000277640