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RECRUITING
NCT05490238
NA

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

Sponsor: IGLESIAS Juan Fernando

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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