Micropuncture vs. Standard Common Femoral Artery Access

NCT02026180 | Terminated

• 1 other identifier: 13-090
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• Arterial perforation

  30 days

• Acute limb ischemia

  Acute limb ischemia, indicated by thrombosis or loss of distal pulses

  30 days

• Arteriovenous fistula

  Arteriovenous fistula, defined as an abnormal communication between an artery and a vein

  30 days

• Access site pseudoaneurysm

  30 days

• Retroperitoneal bleeding

  Retroperitoneal bleeding defined as computerized tomography confirmation of femoral artery hemorrhage into the retroperitoneal space

  30 days

• Groin hematoma

  Groin hematoma, defined as hematoma \>5 cm.

  30 days

• Femoral artery dissection

  Femoral artery dissection confirmed by angiography

  30 days

Study Arms (2)

Micropuncture Access

ACTIVE COMPARATOR

Vascular access using micropuncture needle kit

Device: Micropuncture Access

Standard 18G vascular access needle

ACTIVE COMPARATOR

Vascular access using standard 18G needle

Device: Micropuncture Access

Interventions

Micropuncture Access DEVICE

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

Micropuncture Access; Standard 18G vascular access needle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Arterial access obtained through the radial or brachial artery
• Age less than 18 years
• Patients with known bleeding diathesis

Sponsors & Collaborators

• North Texas Veterans Healthcare System: lead

Study Sites (1)

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 31, 2013
• First Posted: January 1, 2014
• Study Start: December 1, 2013
• Primary Completion: June 1, 2014
• Last Updated: July 15, 2014

Record last verified: 2014-07

Locations

US (1)