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

NCT ID: NCT06688747

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-12-01

Brief Summary

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.

Conditions

Coronary Angiography and Intervention

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Distal access

Distal radial access for coronary angiography and intervention

No interventions assigned to this group

Traditional access

Distal radial access for coronary angiography and intervention

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Aged ≥18 y

2. Signed informed consent form

3. Indication to diagnostic coronary angiography or PCI

4. Patient's suitability for both DRA and conventional TRA using 6 Fr Sheath

Exclusion Criteria

1. Chronic hemodialysis

2. Treatment of a coronary chronic total occlusion (CTO) lesion

3. Patients who underwent CA or PCI with radial access before

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Talaat Bakr

Cardiology specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mostafa Talaat Bakr Mostafa Mostafa Talaat, MD

Role: CONTACT

Mostafatalaat554@gmail.com

0201007952006

References

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.

Reference Type: BACKGROUND

PMID: 33454250 (View on PubMed)

Other Identifiers

AssiutU/Mostafa Talaat

Identifier Type: -

Identifier Source: org_study_id