Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05490238

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

Led by IGLESIAS Juan Fernando · Updated on 2025-12-19

708

Participants Needed

9

Research Sites

195 weeks

Total Duration

On this page

Sponsors

I

IGLESIAS Juan Fernando

Lead Sponsor

U

University of Bern

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �318 years
  • Patients presenting with chronic coronary syndrome or acute coronary syndrome, including unstable angina or NSTEMI
  • Patients planned for PCI of complex coronary lesions such as chronic total occlusion, left main coronary artery disease, heavily calcified lesions, complex bifurcations, or other complex coronary lesions requiring a 7F guiding catheter
  • Patients able to provide written informed consent
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

Clinique St. Joseph Arlon - Groupe Vivalia

Arlon, Belgium

Actively Recruiting

2

CHU Saint-Pierre

Brussels, Belgium

Actively Recruiting

3

CHU de Charleroi

Charleroi, Belgium

Actively Recruiting

4

Hôpital de La Louvière - Site Jolimont

La Louvière, Belgium

Actively Recruiting

5

Agaplesion Bethesda Krankenhaus Bergedorf

Hamburg, Germany

Actively Recruiting

6

Patras University Hospital

Pátrai, Greece

Actively Recruiting

7

Humanitas Research Hospital

Milan, Italy

Actively Recruiting

8

Basel University Hospital

Basel, Basel, Switzerland

Actively Recruiting

9

Geneva University Hospitals

Geneva, Canton of Geneva, Switzerland, 1205

Actively Recruiting

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Research Team

V

Véronique Menoni

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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