Fluoroscopic-Guided Micropuncture Technique for Common Femoral Artery Access

NCT03955653 | Completed

• 1 other identifier: IRB-300001879
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Catheter Related Complication

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• The rate of access site complications

  the procedure

Study Arms (2)

RAO projection

ACTIVE COMPARATOR

Patients will be randomized to right anterior oblique (RAO) projection by fluoroscopy for the access to the femoral artery

Procedure: Femoral artey access

AP projection

ACTIVE COMPARATOR

Patients will be randomized to anterior-posterior projection by fluoroscopy for the access to the femoral artery

Procedure: Femoral artey access

Interventions

Femoral artey access PROCEDURE

We will study the access to the femoral artery for cardiac catheterization or percutaneous coronary intervention

AP projection; RAO projection

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are undergoing cardiac catheterization or PCI

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Leesar MA, Waheed S, Al Solaiman F, Chatterjee A, Daya HA, Hage FG, Brott BC. Randomized trial of an oblique versus standard fluoroscopic-guided micropuncture technique for femoral arterial access: The Micropuncture-CFA trial. Cardiovasc Revasc Med. 2023 Dec;57:43-50. doi: 10.1016/j.carrev.2023.06.029. Epub 2023 Jun 28.

  PMID: 37414613 DERIVED

Study Officials

• Massoud A Leesar, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Patients will be randomized equally to the right anterior oblique view using fluoroscopy and the access to the femoral artery will be compared to that in the anterior-posterior projection

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 20, 2019
• Study Start: April 30, 2019
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: November 26, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)