Micropuncture vs. Standard Common Femoral Artery Access

Vascular Access Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02026180
• Other study ID #: 13-090
• Status: Terminated
• Phase: N/A
• First received: December 31, 2013
• Last updated: July 12, 2014
• Start date: December 2013

Study information

• Verified date: July 2014
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentDallas VA Medical Center Institutional Review BoardDallas VA Medical Center Research and Development Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 552
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vascular Access Complications

Intervention

Device:
• Micropuncture Access
Femoral arterial access will be obtained either with a 21G micropuncture needle kit or an 18G standard access needle.

Locations

Country	Name	City	State
United States	Dallas VA Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
North Texas Veterans Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

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