Femoral Micropuncture or Routine Introducer Study (FEMORIS)

Cook Group

Status: Terminated

Conditions: Complications

Treatments: Device: Micropuncture needle set; Device: Standard gauge-18 needle set

Study type: Interventional

Funder types: Industry

Identifiers

NCT01103141

09-012

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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143 participants in 2 patient groups

Micropuncture

Active Comparator group

Treatment:

Device: Micropuncture needle set

Standard

Active Comparator group

Treatment:

Device: Standard gauge-18 needle set