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

Coronary Angiography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03794687
• Other study ID #: IRB201802924
• Status: Completed
• Start date: April 3, 2019
• Est. completion date: September 15, 2021

Study information

• Verified date: October 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Despite the abundance of data supporting the use of the radial artery compared to the femoral artery, data on the use the distal radial access site in the anatomical snuffbox is limited. Most of the available literature on the distal radial access comes from case reports and small retrospective case series looking primarily at the feasibility and success rates with this approach (4-6). Crossover rate from proximal radial to femoral approach in a prior randomized controlled trial was reported at 3.7% (2). A similar rate has been reported in case series studies of distal radial access, with success rates ranging from 88.6% to 96.3% (4-6). No cases of radial artery occlusion, hematoma, or hand paresthesia were reported in any of these series. Given the promising results with the distal radial approach, its use has expanded to many cardiac catheterization laboratories across the country. However, prospective randomized data comparing distal versus the conventional proximal radial arterial access sites is warranted.

Therefore, the aim of this study is to compile a prospective observational case series to evaluate the safety and feasibility of distal radial artery access in a prospective case series. If an acceptable safety profile can be demonstrated, the case series will be followed with a randomized controlled trial directly comparing distal to standard proximal radial artery approach.

Specific Aims and study hypothesis:

The primary aim of the present study is to assess the safety and feasibility of distal radial arterial access. The study hypothesis is that distal radial access for coronary angiography is associated with similar incidence rates of access site related complications compared to complication rates previously reported with the standard proximal radial artery access.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Coronary Angiography

Intervention

Procedure:
• Left heart catheterization
Catheterization via the distal radial artery

Locations

Country	Name	City	State
United States	University of Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility of distal radial arterial access defined as failure of access within 10 minutes with conversion to an alternative arterial access site.	Failure of access will be defined as inability to obtain access within 10 minutes from initial administration of local anesthetic to successful cannulation of the radial artery.	10 Minutes
Secondary	Patient satisfaction	Patient satisfaction will be assessed with a patient satisfaction survey following the procedure	30 Minutes