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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: April 5, 2017
Last verified: April 2017
  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: Participant, Outcomes Assessor
Primary Purpose: Supportive Care

Further study details as provided by Cook:

Primary Outcome Measures:
  • 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


Enrollment: 143
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 Device: Micropuncture needle set
Groin access for vascular intervention
Active Comparator: Standard Device: Standard gauge-18 needle set
Groin access for vascular intervention

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01103141     History of Changes
Other Study ID Numbers: 09-012
Study First Received: April 12, 2010
Results First Received: February 17, 2017
Last Updated: April 5, 2017

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

ClinicalTrials.gov processed this record on May 25, 2017