NCT04691778

Coronary CTO PCI Using Antegrade Wiring Strategy With a First-choice Gladius Guidewire (Gladius First)

Coronary Chronic Total Occlusion Percutaneous Coronary Intervention Using Antegrade Wiring Strategy With a First-choice Gladius Guidewire: a Randomized Clinical Study (Gladius First Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: National Institute of Cardiology, Warsaw, Poland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Gladius First trial is designed as a single-centre, open, prospective, randomized clinical trial aimed to assess the efficiency and safety of coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using the antegrade wiring strategy with a first-choice intermediate Gladius guidewire. To this end, consecutive patients referred to CTO PCI with intended primary antegrade wire escalation strategy, will be randomized in a 1:1 fashion to antegrade wiring starting with the Gladius guidewire or antegrade wiring using the standard guidewire escalation strategy.

Conditions

• Coronary Artery Disease
• Coronary Occlusion
• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
PROCEDURE	CTO PCI with the first-choice Gladius guidewire	CTO PCI using antegrade wiring strategy with the first-choice Gladius guidewire
PROCEDURE	CTO PCI without the first-choice Gladius guidewire	CTO PCI using standard antegrade wire escalation strategy

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-12-30
• Completion: 2024-01-30
• First posted: 2020-12-31
• Last updated: 2024-10-08

Locations

1 site across 1 country: Poland