Femoral Micropuncture or Routine Introducer Study (FEMORIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01103141
Recruitment Status : Terminated (This original design is no longer consistent with current clinical practice.)
First Posted : April 14, 2010
Results First Posted : April 4, 2017
Last Update Posted : May 11, 2017
Information provided by (Responsible Party):
Cook Group Incorporated

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.

Condition or disease Intervention/treatment Phase
Complications Device: Micropuncture needle set Device: Standard gauge-18 needle set Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Study Start Date : June 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Arm Intervention/treatment
Active Comparator: Micropuncture Device: Micropuncture needle set
Groin access for vascular intervention
Active Comparator: Standard Device: Standard gauge-18 needle set
Groin access for vascular intervention

Primary Outcome Measures :
  1. Major Peripheral Vascular Events [ Time Frame: 7 - 14 days ]
    Major peripheral vascular events occurring during femoral catheterization followed by Percutaneous Coronary Intervention (PCI), which include any of the following: Groin bleeding, including oozing or spurting after standard compression time necessitating further compression; Groin hematoma ≥ 5 cm at any time during or after the procedure; Pseudoaneurysm, confirmed by Doppler ultrasound; Arteriovenous (AV) fistula, confirmed by Doppler ultrasound; Arterial dissection, thrombosis, or embolism; Retroperitoneal bleeding defined by Computed Tomography Angiography (CTA) or surgery; Significant drop in hemoglobin ≥ 3 g/dL, or a drop in hematocrit ≥ 10% within 24-48 hours after the procedure compared to baseline without an obvious non-groin source; Any groin complication delaying hospital discharge; Large ecchymosis (> 15 cm) at the site of vascular access on follow-up (dark purple to black and confluent ecchymoses); Obvious extravascular extravasation of contrast as noted on the femoral

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01103141

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 Group Incorporated

Responsible Party: Cook Group Incorporated Identifier: NCT01103141     History of Changes
Other Study ID Numbers: 09-012
First Posted: April 14, 2010    Key Record Dates
Results First Posted: April 4, 2017
Last Update Posted: May 11, 2017
Last Verified: April 2017

Keywords provided by Cook Group Incorporated:
Vascular Surgical Procedures
Radiology, Interventional