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

RecruitingNAAges 18 Years - anyAllIGLESIAS Juan Fernando
NCT05490238 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

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

9 sites
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, Switzerland

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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