Comparing distal and conventional radial access for complex heart procedures

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

This study is testing if using a different access point in the wrist for heart procedures can make them safer and more effective for patients with complex coronary issues.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 708 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Geneva (Academic / other)
• Locations: 9 sites (Arlon and 8 other locations)
• Trial ID: NCT05490238 on ClinicalTrials.gov

What this trial studies

This study investigates the use of distal radial artery access as an alternative to conventional radial access for patients undergoing complex percutaneous coronary interventions (PCI). It aims to evaluate the feasibility and safety of using a specialized 7F guiding catheter in this context, particularly for challenging coronary lesions. The study is multicenter and observational, involving patients who meet specific criteria related to their coronary conditions. The goal is to determine if distal access can reduce complications and improve outcomes compared to traditional methods.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with complex coronary lesions requiring PCI, such as chronic total occlusions or heavily calcified lesions.

Not a fit: Patients with acute ST-segment elevation myocardial infarction or those with contraindications to transradial access will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to lower rates of vascular complications and improved outcomes for patients undergoing complex heart procedures.

How similar studies have performed: Previous studies have shown promising results with distal radial access, but this specific approach using a 7F guiding catheter is relatively novel.

Eligibility criteria

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.

Where this trial is running

Arlon and 8 other locations

• 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, Switzerland (Recruiting)

Study contacts

• Principal investigator: Juan F. Iglesias, MD — University Hospital, Geneva
• Study coordinator: Véronique Menoni

Conditions Vascular Access Site Occlusion; Radial artery access; Distal radial artery; Complex PCI