Micropuncture vs. Standard Common Femoral Artery Access

NCT ID: NCT02026180

Last Updated: 2014-07-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 552 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31

Brief Summary

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.

Conditions

Vascular Access Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Micropuncture Access

Vascular access using micropuncture needle kit

Group Type: ACTIVE_COMPARATOR

Micropuncture Access

Intervention Type: DEVICE

Femoral arterial access will be obtained either with a 21G micropuncture needle kit or an 18G standard access needle.

Standard 18G vascular access needle

Vascular access using standard 18G needle

Group Type: ACTIVE_COMPARATOR

Micropuncture Access

Intervention Type: DEVICE

Femoral arterial access will be obtained either with a 21G micropuncture needle kit or an 18G standard access needle.

Interventions

Micropuncture Access

Femoral arterial access will be obtained either with a 21G micropuncture needle kit or an 18G standard access needle.

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

1. Arterial access obtained through the radial or brachial artery

2. Age less than 18 years

3. Patients with known bleeding diathesis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

North Texas Veterans Healthcare System

FED

Sponsor Role: lead

Responsible Party

Emmanouil Brilakis

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dallas VA Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

13-090

Identifier Type: -

Identifier Source: org_study_id