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)

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.

Inclusion Criteria:

• delivery of an informed consent and compliance with study protocol
• CTO of a major coronary artery with at least intermediate difficulty score (J-CTO ≥1) as assessed by invasive angiography
• referral to clinically indicated CTO PCI with intended primary antegrade wiring strategy

Exclusion Criteria:

• in-stent CTO
• unstable angina and/or myocardial infarction
• prior myocardial infarction within 4 weeks before study enrolment
• CTO of a major coronary artery with an easy difficulty score (J-CTO 0) as assessed by invasive coronary angiography
• lack of valid antegrade wire escalation strategy as assessed by 2 independent CTO PCI operators
• chronic kidney disease (defined as eGFR ≤30 ml/min/m2)
• contraindication to antiplatelet therapy and/or heparin
• severe inflammatory disease
• positive pregnancy test or breast-feeding