Micropuncture vs. Standard Common Femoral Artery Access

Veterans Affairs (VA) North Texas Health Care System

Status: Terminated

Conditions: Vascular Access Complications

Treatments: Device: Micropuncture Access

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02026180

13-090

Details and patient eligibility

About

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.

Enrollment: 552 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

1. Arterial access obtained through the radial or brachial artery
2. Age less than 18 years
3. Patients with known bleeding diathesis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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552 participants in 2 patient groups

Micropuncture Access

Active Comparator group

Description:

Vascular access using micropuncture needle kit

Treatment:

Device: Micropuncture Access

Standard 18G vascular access needle

Active Comparator group

Description:

Vascular access using standard 18G needle

Treatment:

Device: Micropuncture Access