Clinical trial NCT02026180: Micropuncture vs. Standard Common Femoral Artery Access
Official title: Randomized Comparison of Micropuncture vs. Standard Common Femoral Artery Access for Reducing Vascular Access Complications
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vascular Access Complications
Lead sponsor: North Texas Veterans Healthcare System
Sponsor class: FED
First posted: 2014-01-01
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Arterial perforation
timeFrame: 30 days
measure: Acute limb ischemia
timeFrame: 30 days
measure: Arteriovenous fistula
timeFrame: 30 days
measure: Access site pseudoaneurysm
timeFrame: 30 days
measure: Retroperitoneal bleeding
timeFrame: 30 days
measure: Groin hematoma
timeFrame: 30 days
measure: Femoral artery dissection
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
Study officials:
References: