Skip to main content
OpenTrials
Completed

NCT Number: NCT03986151

Anatomical sNuffbox for Coronary anGiography and IntervEntions

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Patras

Pátrai, Achaia, 26504, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Coronary angiography +/- percutaneous coronary intervention

Procedure

Comparison of the conventional radial approach with the distal radial approach (anatomical snuffbox)

Primary outcomes

  1. Rate of right radial artery occlusion

    Time frame: ≥30 days after CAG or PCI

Secondary outcomes

  1. Rate of successful insertion of the sheath

    Time frame: Immediately post-procedurally

  2. Duration of sheath insertion procedure

    Time frame: Immediately post-procedurally

  3. Rate of successful completion of coronary angiography

    Time frame: Immediately post-procedurally

  4. Rate of successful completion of percutaneous coronary intervention

    Time frame: Immediately post-procedurally

  5. Total Contrast volume

    Time frame: Immediately post-procedurally

  6. Total Fluoroscopy time

    Time frame: Immediately post-procedurally

  7. Total Radiation Dose

    Time frame: Immediately post-procedurally

  8. Total Procedure Time

    Time frame: Immediately post-procedurally

  9. Time required for hemostasis

    Time frame: 1-6 hours

  10. Postprocedural Hematoma (modified EASY class)

    Time frame: 3 hours

  11. Rate of distal radial artery occlusion

    Time frame: ≥30 days after CAG or PCI

  12. Pain associated with the procedure: Pain scale 0-10

    Time frame: 1 hour

    Pain scale 0-10. A visual anlog pain scale 0-10 will be shown to the patient post-precedurally. 0=no pain, 10=worst pain. Patient will be asked to report the severity of the pain associated with the procedure.

Sponsors and collaborators

Lead sponsor

University Hospital of Patras

Other

Registry information

Acronym: ANGIE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 14, 2019
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.