Menu
Not yet recruiting NCT06688747

The Primary Endpoint is to Compare the Incidence of Forearm RAO Between Distal and Traditional Radial Access Assessed by Vascular Ultrasound At Discharge

Observational Coronary Angiography and Intervention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Coronary Angiography and Intervention. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Distal Versus Traditional Radial Access for Coronary Angiography and Intervention

Overview

The primary endpoint is to compare the incidence of forearm RAO between distal and traditional radial access for coronary angiography and intervention

Detailed description

Trans radial access (TRA) has become the standard vascular access for coronary angiography and percutaneous coronary intervention (PCI) and is currently endorsed with a class IA recommendation in the latest European Society of Cardiology/European Association for Cardiothoracic Surgery (ESC/EACTS) Guidelines on myocardial revascularization, irrespective of clinical presentation Several clinical and procedural characteristics have been linked to the occurrence of RAO, and best practices recommendations for the prevention of RAO include reduction of the sheath/catheter size, adequate procedural anticoagulation, non-occlusive hemostasis (4) and a minimal pressure strategy with short (≤ 120 min) hemostasis time. The use of the distal radial artery with arterial access in the anatomical snuffbox or on the dorsum of the hand, has recently emerged as a promising alternative access route to further reduce the risk of RAO (5) The distal radial artery may be punctured proximally to the tendon of the extensor pollicis longus muscle in the anatomical snuffbox or distally to it in the dorsum of the hand.(6) the distal radial artery lies in the subcutaneous space superficial to the fascial compartments of the hand, thus favoring a faster, and safer hemostasis as compared to conventional TRA(7) The study will enroll 228 patients who will undergo a diagnostic coronary angiography and/or a PCI using a 6 Fr Sheath as the standard access sheath will be divided into two groups DRA versus TRA (114 cases in each group) The primary endpoint is the incidence of forearm RAO between the two groups at hospitalization discharge assessed by duplex ultrasound with independent investigator, who was not involved in the procedure. The presence or absence of a duplex ultrasound anterograde flow signal distal to the radial artery access site is checked between 8 to 48 hours post-procedure The secondary endpoints as successful sheath insertion, access site cross-over, total procedure time, sheath insertion time, puncture site bleeding overall bleeding, vascular access-site complication and radial artery spasm.

Primary outcome measures

  • To compare the incidence of forearm RAO between distal and traditional radial access assessed by vascular ultrasound at discharge [Time frame: One year]

Eligibility criteria

Inclusion criteria

  • Aged ≥18 y
  • Signed informed consent form
  • Indication to diagnostic coronary angiography or PCI
  • Patient's suitability for both DRA and conventional TRA using 6 Fr Sheath

Exclusion criteria

  • Chronic hemodialysis
  • Treatment of a coronary chronic total occlusion (CTO) lesion
  • Patients who underwent CA or PCI with radial access before

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Sgueglia GA, Santoliquido A, Gaspardone A, Di Giorgio A. First Results of the Distal Radial Access Doppler Study. JACC Cardiovasc Imaging. 2021 Jun;14(6):1281-1283. doi: 10.1016/j.jcmg.2020.11.023. Epub 2021 Jan 13. No abstract available. PMID 33454250

Identifiers

NCT: NCT06688747 · AssiutU/Mostafa Talaat

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗