Femoral Micropuncture or Routine Introducer Study

Study Overview
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Brief Summary
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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.

Conditions
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Complications

Intervention / Treatment
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* Device: Micropuncture needle set
* Device: Standard gauge-18 needle set


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Micropuncture<br> | Device: Micropuncture needle set<br>* Groin access for vascular intervention<br>|
| Active Comparator: Standard<br> | Device: Standard gauge-18 needle set<br>* Groin access for vascular intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 7 - 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular Surgical Procedures, Angioplasty, Radiology, Interventional