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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
Clinique St. Joseph Arlon - Groupe Vivalia
RECRUITING
Arlon
CHU Saint-Pierre
RECRUITING
Brussels
CHU de Charleroi
RECRUITING
Charleroi
Hôpital de La Louvière - Site Jolimont
RECRUITING
La Louvière
Greece
Patras University Hospital
RECRUITING
Pátrai
Italy
Humanitas Research Hospital
RECRUITING
Milan
Switzerland
Basel University Hospital
RECRUITING
Basel
Geneva University Hospitals
RECRUITING
Geneva
Contact Information
Primary
Maëlle Achard, RN
maelle.achard@hcuge.ch
+41795533553
Time Frame
Start Date: 2023-08-31
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 708
Treatments
Experimental: Distal radial access
Distal radial access using 7Fr Glidesheath Slender sheath (Terumo Corp., Japan)
Active_comparator: Conventional radial access
Conventional radial access using 7Fr Glidesheath Slender sheath (Terumo Corp., Japan)
Sponsors
Leads: IGLESIAS Juan Fernando
Collaborators: University of Bern

This content was sourced from clinicaltrials.gov