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

Tracking Information
First Received Date ^ICMJE	April 12, 2010
Last Updated Date	February 7, 2012
Start Date ^ICMJE	June 2010
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 13, 2010)	Incidence of access site complications [ Time Frame: 7 - 14 days ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01103141 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Femoral Micropuncture or Routine Introducer Study
Official Title ^ICMJE	Not Provided
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Supportive Care
Condition ^ICMJE	Complications
Intervention ^ICMJE	Device: Micropuncture needle set Groin access for vascular intervention Device: Standard gauge-18 needle set Groin access for vascular intervention
Study Arm (s)	Active Comparator: Micropuncture Micropuncture Intervention: Device: Micropuncture needle set Active Comparator: Standard Standard Intervention: Device: Standard gauge-18 needle set
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	144
Completion Date	April 2011
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01103141
Other Study ID Numbers ^ICMJE	09-012
Has Data Monitoring Committee	Not Provided
Responsible Party	Cook
Study Sponsor ^ICMJE	Cook
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Cook
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top