Micropuncture vs. Standard Common Femoral Artery Access

Not Applicable

Terminated

• Conditions: Vascular Access Complications
• Interventions: Device: Micropuncture Access

• Registration Number: NCT02026180
• Lead Sponsor: North Texas Veterans Healthcare System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-31
• Study First Submitted QC: 2013-12-31
• Study First Posted: 2014-01-01
• Primary Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-12
• Last Update Posted: 2014-07-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 552

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Micropuncture Access	Micropuncture Access	Vascular access using micropuncture needle kit
Standard 18G vascular access needle	Micropuncture Access	Vascular access using standard 18G needle

Primary Outcome Measures

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

Trial Locations

Locations (1)

Dallas VA Medical Center; 🇺🇸 Dallas, Texas, United States