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

NCT05490238 | Recruiting

• 1 other identifier: 2022-0729
• Study Type: interventional
• Target: 708
• Locations: 5 countries
• Sites: 9

Brief 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.

Conditions

Vascular Access Site Occlusion

Keywords

Radial artery access; Distal radial artery; Complex PCI

Outcome Measures

Primary Outcomes (1)

• Incidence of forearm radial artery occlusion

  US Doppler

  At hospital discharge (assessed up to day 5)

Secondary Outcomes (8)

• Incidence of vascular access site-related bleeding

  At hospital discharge (assessed up to day 5)

• Incidence of vascular access site-related complication

  At hospital discharge (assessed up to day 5)

• Incidence of radial artery spasm

  During intervention (up to day 1)

• Incidence of distal radial artery occlusion

  At hospital discharge (assessed up to day 5)

• Total hemostasis time

  At hospital discharge (assessed up to day 5)

Study Arms (2)

Distal radial access

EXPERIMENTAL

Distal radial access using 7Fr Glidesheath Slender sheath (Terumo Corp., Japan)

Procedure: Complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan)

Conventional radial access

ACTIVE COMPARATOR

Conventional radial access using 7Fr Glidesheath Slender sheath (Terumo Corp., Japan)

Procedure: Complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan)

Interventions

Complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan) PROCEDURE

Large-bore radial access for complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan)

Conventional radial access; Distal radial access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• IGLESIAS Juan Fernando: lead
• University of Bern: collaborator

Study Sites (9)

Clinique St. Joseph Arlon - Groupe Vivalia

Arlon, Belgium

RECRUITING

CHU Saint-Pierre

Brussels, Belgium

RECRUITING

CHU de Charleroi

Charleroi, Belgium

RECRUITING

Hôpital de La Louvière - Site Jolimont

La Louvière, Belgium

RECRUITING

Agaplesion Bethesda Krankenhaus Bergedorf

Hamburg, Germany

RECRUITING

Patras University Hospital

Pátrai, Greece

RECRUITING

Humanitas Research Hospital

Milan, Italy

RECRUITING

Basel University Hospital

Basel, Basel, Switzerland

RECRUITING

Geneva University Hospitals

Geneva, Canton of Geneva, 1205, Switzerland

RECRUITING

Related Publications (1)

• Iglesias JF, Leibundgut G, Heg D, Gasparini GL, Tsigkas G, Ungureanu C, Colletti G, Degrauwe S, Xaplanteris P, Schenke K, Achim A, van Leeuwen MA, Muresan M, Saito S, Sgueglia GA, Aminian A. Distal versus conventional radial large-bore access for percutaneous coronary intervention of complex coronary lesions: Rationale and design of the DISCO COMPLEX randomized superiority trial. Am Heart J. 2026 Feb;292:107291. doi: 10.1016/j.ahj.2025.107291. Epub 2025 Oct 18.

  PMID: 41115584 DERIVED

Study Officials

• Juan F. Iglesias, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique Menoni

CONTACT

+41795530516; veronique.menoni@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 5, 2022
• Study Start: August 31, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication of the study primary and secondary endpoints.

Locations

DE (1); IT (1); CH (2); GR (1); BE (4)