Clinical Research Directory
Browse clinical research sites, groups, and studies.
DIStal Versus COnventional Radial Access for COMPLEX Large-bore Percutaneous Coronary Intervention
Sponsor: IGLESIAS Juan Fernando
Summary
The use of the distal radial artery has recently emerged as a promising alternative access route to further reduce the risk of radial artery occlusion (RAO) and has been endorsed by recent International Consensus documents. The feasibility of a distal radial access (DRA) for coronary angiography and/or PCI has been demonstrated in several observational clinical registries and small-sized randomized clinical trials. In the recent prospective, multicenter, open label, randomized, controlled DIStal vs Conventional RADIAL access (DISCO RADIAL) trial, DRA was associated with low and similar rates of RAO at discharge when compared to conventional TRA among patients undergoing coronary angiography and/or PCI. There is however limited evidence on the feasibility and safety of 7F DRA for PCI. In a prospective, multicenter, observational study including 41 patients undergoing CTO PCI using a left DRA with a 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan), technical success was achieved in 90.3% of patients and procedural success was achieved in 78.1% of patients. No post-procedural DRA RAO were detected by clinical assessment and Doppler ultrasound examination, and no radial artery occlusions at the site of the forearm were found. Doppler ultrasound imaging of the DRA at one month was available in 67.6% of patients, with only one case (4.3%) of DRA RAO. This proof-of-concept study demonstrates that DRA using a 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan) for CTO PCI is feasible and associated with a high procedural success rate and low vascular access-site complication rates. No randomized clinical trial to date has however compared the feasibility and safety of a 7F DRA versus 7F TRA for PCI of complex coronary lesions, such as chronic total occlusions (CTO), left main coronary artery disease, heavily calcified lesions, complex bifurcations, or other complex coronary lesions for whom the operator anticipates that a 7F guiding catheter is indicated.
Official title: DIStal Versus COnventional Radial Access for COMPLEX Large-bore Percutaneous Coronary Intervention (DISCO COMPLEX)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
708
Start Date
2023-08-31
Completion Date
2027-06-01
Last Updated
2025-12-19
Healthy Volunteers
No
Conditions
Interventions
Complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan)
Large-bore radial access for complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan)
Locations (9)
Clinique St. Joseph Arlon - Groupe Vivalia
Arlon, Belgium
CHU Saint-Pierre
Brussels, Belgium
CHU de Charleroi
Charleroi, Belgium
Hôpital de La Louvière - Site Jolimont
La Louvière, Belgium
Agaplesion Bethesda Krankenhaus Bergedorf
Hamburg, Germany
Patras University Hospital
Pátrai, Greece
Humanitas Research Hospital
Milan, Italy
Basel University Hospital
Basel, Basel, Switzerland
Geneva University Hospitals
Geneva, Canton of Geneva, Switzerland