Clinical trial NCT03986151: Anatomical sNuffbox for Coronary anGiography and IntervEntions
Official title: Anatomical sNuffbox for Coronary anGiography and IntervEntions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Vascular Access Complication
Keywords: coronary angiography
radial access
distal radial access
anatomical snuffbox
radial artery occlusion
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 1042
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized, single-center, prospective study seeks to compare the conventional radial approach with the recently described distal radial approach (anatomical snuffbox) concerning the patency of the radial artery in patients subjected to coronary angiography or percutaneous coronary intervention.

Detailed description: Transradial approach has become the standard approach for coronary angiography (CAG) and percutaneous coronary intervention (PCI). The current ESC/EACTS guidelines of myocardial revascularization support using radial approach (RA) rather than femoral approach (FA) if the operators are experts for RA. Recently, an alternative transradial access has been suggested at the anatomical snuffbox, with potential additional benefits including a reduction in radial artery occlusion rate (which allows reintervention through the same access site and potential use as a graft), a decrease in other local vascular complications, shorter hemostasis duration, patients' intra and post procedural comfort and shorter recovery time. However, the feasibility of PCI via snuffbox approach is still concerned due to the lack of data. Therefore, the aim of the study is to compare the two approaches concerning the patency of the radial artery ≥30 days after the intervention with Doppler in a randomized way. Due to the anastomosis of the distal radial artery with the superficial palmar arch, even in case of total radial artery occlusion within the anatomical snuffbox, the antegrade blood flow may be preserved and, therefore, decreased incidents of radial artery occlusion are expected in the right distal radial artery approach group. The mean diameter of radial artery at the anatomical snuffbox is 2.4 mm, whereas the mean diameter of the radial artery at the forearm is 2.7 mm, and this could potentially contribute to shorter hemostasis duration.

Eligibility criteria: Inclusion Criteria:

* Indication for coronary angiography
* Informed consent

Exclusion Criteria:

* Non palpable right radial artery
* Prior complicated right transradial intervention (radial artery dissection, perforation, occlusion)
* Prior CABG
* STEMI
* Hemodynamic instability
* Anatomical restrictions (fistula, etc)

Primary outcomes:
measure: Rate of right radial artery occlusion
timeFrame: ≥30 days after CAG or PCI
Secondary outcomes:
measure: Rate of successful insertion of the sheath
timeFrame: Immediately post-procedurally
measure: Duration of sheath insertion procedure
timeFrame: Immediately post-procedurally
measure: Rate of successful completion of coronary angiography
timeFrame: Immediately post-procedurally
measure: Rate of successful completion of percutaneous coronary intervention
timeFrame: Immediately post-procedurally
measure: Total Contrast volume
timeFrame: Immediately post-procedurally
measure: Total Fluoroscopy time
timeFrame: Immediately post-procedurally
measure: Total Radiation Dose
timeFrame: Immediately post-procedurally
measure: Total Procedure Time
timeFrame: Immediately post-procedurally
measure: Time required for hemostasis
timeFrame: 1-6 hours
measure: Postprocedural Hematoma (modified EASY class)
timeFrame: 3 hours
measure: Rate of distal radial artery occlusion
timeFrame: ≥30 days after CAG or PCI
measure: Pain associated with the procedure: Pain scale 0-10
timeFrame: 1 hour
Other outcomes:
Locations:
city: Patras
country: Greece
facility: University Hospital of Patras
state: Achaia
Study officials:
affiliation: University Hospital of Patras
name: Grigorios Tsigkas, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: