Femoral Micropuncture or Routine Introducer Study

Not Applicable

Terminated

• Conditions: Complications
• Interventions: Device: Standard gauge-18 needle set; Device: Micropuncture needle set

• Registration Number: NCT01103141
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-14
• Study Start: 2010-06
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2017-02-17
• Results First Submitted QC: 2017-02-17
• Status Verified: 2017-04
• Results First Posted: 2017-04-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	Standard gauge-18 needle set	-
Micropuncture	Micropuncture needle set	-

Primary Outcome Measures

Name	Time	Method
Major Peripheral Vascular Events	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

Trial Locations

Locations (2)

University of California, San Francisco, Fresno, School of Medicine; 🇺🇸 Fresno, California, United States

St. Vincent Hospital; 🇺🇸 Indianapolis, Indiana, United States