Fluoroscopic-Guided Micropuncture Technique for Common Femoral Artery Access (ACCESS)

Fluoroscopic-Guided Micropuncture Technique for Common Femoral Artery Access: Comparisons of Oblique vs. Antero-Posterior Projections for Femoral Artery Access

The main objective of this proposed study is to examine if oblique projection (20- degrees right anterior oblique (RAO) for right femoral artery access or 20-degree left anterior oblique (LAO) for left femoral artery access) is superior to anterior projection (AP) for femoral artery access in zone 2-4 and thereby resulting in lower risk of access related complications.

Study Overview

• Status: Completed
• Conditions: Catheter Related Complication
• Intervention / Treatment: Procedure: Femoral artey access

Detailed Description

The investigators plan to randomize 200 subjects who present for coronary angiography, bypass graph angiography or left heart catheterization via the femoral approach. The investigators will randomly assign them to either oblique projection (20-degree RAO for right femoral artery) or 20-degree LAO (for left femoral artery) versus AP for femoral arterial access in a 1:1 fashion. A trained cardiologist will review the femoral artery angiogram. The investigators will use the scoring system used for the femoral artery access site, as previously reported (10). These predefined locations are as follows: zone 1 denotes femoral artery above the femoral head; zone 2, femoral artery from the superior border of femoral head to the center of the femoral head; zone 3, femoral artery in the center of the femoral head; zone 4, femoral artery from the center of femoral head to the inferior border of the femoral head; and zone 5, femoral artery below the inferior boarder of the femoral head.

The invesigators will use micropuncture access kit for femoral artery access. Micropuncture needle will be advanced to the center of the femoral head and common femoral artery will be punctured guided by fluoroscopy. Those assigned to oblique projection will have fluoroscopic-guided femoral access in RAO 20 degree for right femoral artery and LAO 20 degree for left femoral artery, while those assigned to AP will have femoral artery access in AP 0 degree. For both groups, the investigators will also obtain the other view as a reference to compare results (i.e., in the oblique group, we will save AP and vice versa). If the tip of the micropuncture needle were located in the femoral artery corresponding to the center (zone 3) or bottom third (zone 4) of the femoral head in the 20-degree RAO, 20-degree LAO position or zero-degree AP position, the micropuncture dilator will be advanced into the femoral artery, 0.018" guide wire will be exchanged with a 0.035" guide wire, and a sheath will be placed in the femoral artery, and the femoral angiography will be performed in the 20-degree RAO or 20-degree LAO projection for right and left femoral artery, respectively.

The investigators will also collect data on demographic characteristics including age, race, gender, as well as cardiovascular risk factors such as history of diabetes, hypertension, dyslipidemia, peripheral arterial disease, prior CAD, prior CVA, smoking history, family history of CAD, eGFR. We will also obtain data on medication history to review if they are on antiplatelet or anticoagulants. Those with ipsilateral access within the past 90 days will be excluded.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • UAB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who are undergoing cardiac catheterization or PCI

Exclusion Criteria:

• Peripheral vascular disease
• Renal failure, Creatinine >2.5 mg/dL
• Hemodynamic instability, acute myocardial infarction
• Heart failure with EF<25%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RAO projection; Patients will be randomized to right anterior oblique (RAO) projection by fluoroscopy for the access to the femoral artery	Procedure: Femoral artey access; We will study the access to the femoral artery for cardiac catheterization or percutaneous coronary intervention
Active Comparator: AP projection; Patients will be randomized to anterior-posterior projection by fluoroscopy for the access to the femoral artery	Procedure: Femoral artey access; We will study the access to the femoral artery for cardiac catheterization or percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of access to the central portion of the femoral artery (Zone III)	We will assess the access to the center of the femoral artery after insertion of the sheath for heart catheterization or PCI	the procedure
The success rate of access to the Zone III	We will define the access to the zone III with angiography	the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of access site complications	Hematoma, bleeding complication, femoral artery dissection, pseudoaneurysm	the procedure

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Massoud A Leesar, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2019
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 22, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IRB-300001879

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No