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

National Institute of Cardiology, Warsaw, Poland

Status: Completed

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Coronary Occlusion

Treatments: Procedure: CTO PCI with the first-choice Gladius guidewire; Procedure: CTO PCI without the first-choice Gladius guidewire

Study type: Interventional

Funder types: Other

Identifiers

NCT04691778

2.59/III/20

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

69 participants in 2 patient groups

CTO PCI using antegrade wiring strategy starting with the Gladius guidewire

Active Comparator group

Description:

Study subjects will undergo CTO PCI with primary antegrade wiring strategy starting with the Gladius guidewire. In case of failed CTO crossing with the Gladius wire, the decision on continuing antegrade wire escalation with a different wire or switching to a different CTO PCI strategy will be left to the discretion of the operator.

Treatment:

Procedure: CTO PCI with the first-choice Gladius guidewire

CTO PCI using standard antegrade wire escalation strategy

Other group

Description:

Control subjects will undergo CTO PCI using standard antegrade wiring strategy starting with the lower/intermediate penetration force guidewires and, if necessary, escalating up to high gram-force guidewires, but without the use of first-choice Gladius guidewire.

Treatment:

Procedure: CTO PCI without the first-choice Gladius guidewire