Micropuncture vs. Standard Common Femoral Artery Access

Study Overview
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Brief Summary
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Vascular access complications can occur during or after cardiac or peripheral arterial catheterization. These complications increase patient morbidity and mortality, as well as healthcare costs. Several strategies and devices have been employed to decrease the risk for vascular access complications, such as fluoroscopy-guided access, ultrasound-guided access and vascular closure devices. Randomized trial data has failed to demonstrate that fluoroscopic guidance reduces common femoral artery access complications. While meta-analysis data has demonstrated that vascular closure devices decrease time to arterial hemostasis, increase patient mobilization and facilitate earlier patient discharge, they do not reduce the incidence of vascular complications as compared to hemostasis achieved with manual pressure. Ultrasound guidance has been shown to facilitate femoral artery access and reduce femoral artery vascular complications. A new device, the Micropuncture Kit (Cook Medical, Bloomington, IN) allows vascular access with a small 21gauge needle as opposed to the standard method, which requires an 18 gauge needle. The use of the Micropuncture Kit for the purpose of decreasing vascular access complications has not been examined in a randomized study to date. The present study is a 552 patient randomized controlled clinical trial that will help determine whether femoral arterial access obtained using the Micropuncture Kit will reduce the incidence of vascular access complications compared to the standard 18 gauge needle. The specific aim of this proposal is to compare the rate of femoral artery access complications using the Micropuncture Kit vs. standard femoral artery access. It is our hypothesis that the incidence of femoral artery access complications will be lower among patients in whom the Micropuncture Kit is used.

Official Title
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Randomized Comparison of Micropuncture vs. Standard Common Femoral Artery Access for Reducing Vascular Access Complications

Conditions
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Vascular Access Complications

Intervention / Treatment
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* Device: Micropuncture Access


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing left heart or peripheral catheterization through the common femoral artery with anticipated or possible percutaneous coronary or peripheral intervention Exclusion Criteria: Arterial access obtained through the radial or brachial artery Age less than 18 years Patients with known bleeding diathesis

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Micropuncture Access<br>Vascular access using micropuncture needle kit | Device: Micropuncture Access<br>* Femoral arterial access will be obtained either with a 21G micropuncture needle kit or an 18G standard access needle.<br>|
| Active Comparator: Standard 18G vascular access needle<br>Vascular access using standard 18G needle | Device: Micropuncture Access<br>* Femoral arterial access will be obtained either with a 21G micropuncture needle kit or an 18G standard access needle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial perforation |  | 30 days | 
| Acute limb ischemia | Acute limb ischemia, indicated by thrombosis or loss of distal pulses | 30 days | 
| Arteriovenous fistula | Arteriovenous fistula, defined as an abnormal communication between an artery and a vein | 30 days | 
| Access site pseudoaneurysm |  | 30 days | 
| Retroperitoneal bleeding | Retroperitoneal bleeding defined as computerized tomography confirmation of femoral artery hemorrhage into the retroperitoneal space | 30 days | 
| Groin hematoma | Groin hematoma, defined as hematoma >5 cm. | 30 days | 
| Femoral artery dissection | Femoral artery dissection confirmed by angiography | 30 days |