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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
143
Groin access for vascular intervention
Groin access for vascular intervention
University of California, San Francisco, Fresno, School of Medicine
Fresno, California, United States
St. Vincent Hospital
Indianapolis, Indiana, United States
Major Peripheral Vascular Events
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
Time frame: 7 - 14 days
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