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Femoral Micropuncture or Routine Introducer Study (FEMORIS)

This study has been terminated.
(This original design is no longer consistent with current clinical practice.)
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01103141
First received: April 12, 2010
Last updated: February 7, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Complications
 Device: Micropuncture needle set
Device: Standard gauge-18 needle set

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care

Further study details as provided by Cook:

Primary Outcome Measures:
  • Incidence of access site complications [ Time Frame: 7 - 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 144
Study Start Date: June 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Micropuncture
Micropuncture
 Device: Micropuncture needle set
Groin access for vascular intervention
Active Comparator: Standard
Standard
 Device: Standard gauge-18 needle set
Groin access for vascular intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103141

Locations
United States, California
University of California, San Francisco, Fresno, School of Medicine
Fresno, California, United States, 93701
United States, Indiana
St. Vincent Hospital
Indianapolis, Indiana, United States, 46290
Sponsors and Collaborators
Cook
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01103141     History of Changes
Other Study ID Numbers: 09-012
Study First Received: April 12, 2010
Last Updated: February 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cook:
Vascular Surgical Procedures
Angioplasty
Radiology, Interventional

ClinicalTrials.gov processed this record on May 19, 2013