Femoral Micropuncture or Routine Introducer Study

Stopped early · Not applicable

Conditions studied: Complications

In brief

FEMORIS is a marketing study approved by institutional review boards to compare the rates of complications found when using either the Micropuncture® needle introducer or a standard gauge-18 needle to access the groin blood vessels.

Key facts

Study ID

NCT01103141

Run by

Cook Group Incorporated

People needed

143

Starts

2010-06-01

Expected to finish

2011-04-01

Last updated by the study team

2017-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Undergoing left heart catheterization with anticipated or possible percutaneous coronary intervention

You may not qualify if…

• Left heart cardiac catheterization purely for diagnostic purposes where percutaneous coronary intervention is not anticipated
• Catheterization utilizes primary vascular access site other than the groin
• Catheterization is intended for right heart procedure alone or combined with left and right heart procedures
• Age less than 18 years
• Patient has planned intervention or access utilizing the same groin within 14 days

Where it is running

• University of California, San Francisco, Fresno, School of Medicine — Fresno, California, United States
• St. Vincent Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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