The Distal (SnUffbox) Radial artERy Access for Coronary Angiography and Interventions (SUPER-Prospective)
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | April 3, 2019 |
| End Date: | January 2020 |
| Contact: | Allen Brown, MD |
| Email: | allen.brown@jax.ufl.edu |
| Phone: | 904-244-5915 |
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.
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.
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.
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.
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.
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