The Distal (SnUffbox) Radial artERy Access for Coronary Angiography and Interventions (SUPER-Prospective)

NCT03794687 | Completed

• 1 other identifier: IRB201802924
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The study team aims to perform a prospective observational case series of one hundred consecutive distal radial artery heart catheterizations to evaluate the safety and feasibility of distal radial access. Distal radial artery access has evolved in the past few years as an alternative to the standard radial artery access for coronary angiography and interventions. However, the available data on the distal radial artery access for coronary angiography and interventions is limited to case reports and small retrospective case series. To date, no prospective randomized data is available. Therefore, the investigators aim to perform a prospective observational case series of one hundred sequential left heart catheterizations performed via distal radial artery to evaluate the safety and feasibility of the distal radial artery access.

Conditions

Coronary Angiography

Keywords

Left heart catheterizations

Outcome Measures

Primary Outcomes (1)

• Safety of distal radial arterial access

  Incidence of any radial access complication defined as the composite of radial artery occlusion, radial artery vasospasm, other access site related bleeding or vascular complications, or hand dysfunction

  10 Minutes

Secondary Outcomes (2)

• Feasibility of distal radial arterial access defined as failure of access within 10 minutes with conversion to an alternative arterial access site.

  10 Minutes

• Patient satisfaction

  30 Minutes

Study Arms (1)

Distal Radial Artery

Left heart catheterization via the distal radial artery (dorsal aspect of the hand at the base of the thumb).

Procedure: Left heart catheterization

Interventions

Left heart catheterization PROCEDURE

Catheterization via the distal radial artery

Distal Radial Artery

Eligibility Criteria

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

Study Population

Data of up to one hundred consecutive patients undergoing left heart catheterization via the distal radial artery (dorsal aspect of the hand at the base of the thumb) will be collected.

You may qualify if:

• Patients scheduled to undergo diagnostic left heart catheterization with or without percutaneous coronary intervention.

You may not qualify if:

• Hemodynamically unstable (on vasopressor continuous infusion, on mechanical support) patients.
• Patients undergoing emergent left heart catheterization for ST-elevation myocardial infarction.
• Full oral anticoagulation defined as use of a direct oral anticoagulant (DOAC) within 24 hours or an INR over 2.0 the day of the procedure.
• Active bleeding or known history of blood dyscrasia or bleeding diathesis.
• History of ipsilateral arteriovenous fistula or vascular surgical intervention.
• Patients unable to undergo distal radial artery access due to anatomical deformities, limited mobility, or other.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Jacksonville, Florida, 32209, United States

Location

Study Officials

• Andres Pineda Maldonado, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 7, 2019
• Study Start: April 3, 2019
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

US (1)