An observational study in Coronary Angiography and Intervention, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by Assiut University · Observational
The primary endpoint is to compare the incidence of forearm RAO between distal and traditional radial access for coronary angiography and intervention
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.
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's planned enrollment of 230 is above the median of 183 across 1,099 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
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The study will include patients will undergo coronary angiography and\or PCI in Assiut university heart hospital
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Distal radial access for coronary angiography and intervention
Distal radial access for coronary angiography and intervention
To compare the incidence of forearm RAO between distal and traditional radial access assessed by vascular ultrasound at discharge
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 and follow up after 3 months
Time frame: One year
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Dec 2024; primary completion for Dec 2025, 12 months later.
Of 330 non-industry observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 86. This study's planned 12 months is below that.
Counting every sponsor, half of 429 studies reached it within 28 months; a quarter within 16 and three quarters within 62.
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This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →