Micropuncture vs. Standard Common Femoral Artery Access

This study has been terminated.
(low incidence of primary endpoint)
Sponsor:
Information provided by (Responsible Party):
Emmanouil Brilakis, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT02026180
First received: December 31, 2013
Last updated: July 12, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Vascular Access Complications
Device: Micropuncture Access

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Micropuncture vs. Standard Common Femoral Artery Access for Reducing Vascular Access Complications

Further study details as provided by North Texas Veterans Healthcare System:

Primary Outcome Measures:
  • Arterial perforation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Acute limb ischemia [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Acute limb ischemia, indicated by thrombosis or loss of distal pulses

  • Arteriovenous fistula [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Arteriovenous fistula, defined as an abnormal communication between an artery and a vein

  • Access site pseudoaneurysm [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Retroperitoneal bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Retroperitoneal bleeding defined as computerized tomography confirmation of femoral artery hemorrhage into the retroperitoneal space

  • Groin hematoma [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Groin hematoma, defined as hematoma >5 cm.

  • Femoral artery dissection [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Femoral artery dissection confirmed by angiography


Estimated Enrollment: 552
Study Start Date: December 2013
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Micropuncture Access
Vascular access using micropuncture needle kit
Device: Micropuncture Access
Femoral arterial access will be obtained either with a 21G micropuncture needle kit or an 18G standard access needle.
Active Comparator: Standard 18G vascular access needle
Vascular access using standard 18G needle
Device: Micropuncture Access
Femoral arterial access will be obtained either with a 21G micropuncture needle kit or an 18G standard access needle.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02026180

Locations
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Sponsors and Collaborators
North Texas Veterans Healthcare System
  More Information

No publications provided

Responsible Party: Emmanouil Brilakis, MD, PhD, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT02026180     History of Changes
Other Study ID Numbers: 13-090
Study First Received: December 31, 2013
Last Updated: July 12, 2014
Health Authority: United States: Federal Government
Dallas VA Medical Center Institutional Review Board
Dallas VA Medical Center Research and Development Committee

ClinicalTrials.gov processed this record on August 19, 2014