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

Recruiting now · Not applicable

Conditions studied: Vascular Access Site Occlusion

In brief

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.

Key facts

Study ID: NCT05490238
Run by: IGLESIAS Juan Fernando
People needed: 708
Starts: 2023-08-31
Expected to finish: 2027-06-01
Last updated by the study team: 2025-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥18 years.
Patients presenting with CCS or ACS, including unstable angina or NSTEMI.
Patients planned for PCI of complex coronary lesions, such as CTO, left main coronary artery disease, heavily calcified lesions, complex bifurcations, or other complex coronary lesions in whom the operator anticipates that a 7F guiding catheter is indicated.
Patients able to provide written informed consent.

You may not qualify if…

Patients with acute ST-segment elevation myocardial infarction.
Patients with cardiogenic shock.
Patients on chronic hemodialysis.
Patients with contraindications to TRA, such as occlusive upper arm peripheral artery disease, or known anatomic variants prohibiting TRA on both sides.
Patients with medical conditions that may cause non-compliance with the study protocol and/or may confound the data interpretation.
Patients unable to provide written informed consent.

Where it is running

Clinique St. Joseph Arlon - Groupe Vivalia — Arlon, Belgium (enrolling)
CHU Saint-Pierre — Brussels, Belgium (enrolling)
CHU de Charleroi — Charleroi, Belgium (enrolling)
Hôpital de La Louvière - Site Jolimont — La Louvière, Belgium (enrolling)
Agaplesion Bethesda Krankenhaus Bergedorf — Hamburg, Germany (enrolling)
Patras University Hospital — Pátrai, Greece (enrolling)
Humanitas Research Hospital — Milan, Italy (enrolling)
Basel University Hospital — Basel, Basel, Switzerland (enrolling)
Geneva University Hospitals — Geneva, Canton of Geneva, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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