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Clinical Trials/NCT03986151
NCT03986151
Completed
Not Applicable

Anatomical sNuffbox for Coronary anGiography and IntervEntions

University Hospital of Patras1 site in 1 country1,042 target enrollmentJune 11, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
University Hospital of Patras
Enrollment
1042
Locations
1
Primary Endpoint
Rate of right radial artery occlusion
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 11, 2019
End Date
February 20, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital of Patras
Responsible Party
Principal Investigator
Principal Investigator

Grigorios Tsigkas

Cardiology consultant

University Hospital of Patras

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
  • Hemodynamic instability
  • Anatomical restrictions (fistula, etc)

Outcomes

Primary Outcomes

Rate of right radial artery occlusion

Time Frame: ≥30 days after CAG or PCI

Secondary Outcomes

  • Rate of successful insertion of the sheath(Immediately post-procedurally)
  • Duration of sheath insertion procedure(Immediately post-procedurally)
  • Rate of successful completion of percutaneous coronary intervention(Immediately post-procedurally)
  • Total Procedure Time(Immediately post-procedurally)
  • Pain associated with the procedure: Pain scale 0-10(1 hour)
  • Rate of successful completion of coronary angiography(Immediately post-procedurally)
  • Total Fluoroscopy time(Immediately post-procedurally)
  • Rate of distal radial artery occlusion(≥30 days after CAG or PCI)
  • Total Contrast volume(Immediately post-procedurally)
  • Postprocedural Hematoma (modified EASY class)(3 hours)
  • Total Radiation Dose(Immediately post-procedurally)
  • Time required for hemostasis(1-6 hours)

Study Sites (1)

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