Comparing Distal and Conventional Radial Artery Access Using 7F Glidesheath Slender for Complex Large-Bore Coronary Interventions

What this Trial Is About

Researchers are investigating the use of distal radial artery access compared to conventional radial artery access for complex large-bore percutaneous coronary interventions PCI in patients with complex coronary lesions such as chronic total occlusions, left main coronary artery disease, heavily calcified lesions, and complex bifurcations. This trial aims to evaluate the feasibility and safety of using a 7F Glidesheath Slender sheath for distal radial access, as limited data exist on its use for PCI in these complex cases. The study addresses the risk of radial artery occlusion and other vascular complications associated with different radial access sites. Participants will be randomly assigned to receive PCI through either distal radial access or conventional radial access, both using a 7F Glidesheath Slender sheath Terumo Corp., Japan. The study compares these two approaches during PCI with the Ultimaster family drug-eluting stent in complex coronary lesions. This trial is prospective, multicenter, and open-label, focusing on large-bore radial access and its impact on procedural success and vascular complications. During the study, participants will be monitored for radial artery occlusion and other access site complications up to hospital discharge, typically within five days after PCI. Assessments include clinical evaluation and Doppler ultrasound imaging. Researchers will also measure vascular access site bleeding, radial artery spasm, hemostasis time, pain, hand function up to one year, and target lesion failure at one year. Participants provide informed consent and are followed for outcomes relevant to vascular access safety and procedural success.

DIStal Versus COnventional Radial Access for COMPLEX Large-bore Percutaneous Coronary Intervention