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

NCT ID: NCT04691778

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-01-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CTO PCI using antegrade wiring strategy starting with the Gladius guidewire

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.

Group Type: ACTIVE_COMPARATOR

CTO PCI with the first-choice Gladius guidewire

Intervention Type: PROCEDURE

CTO PCI using antegrade wiring strategy with the first-choice Gladius guidewire

CTO PCI using standard antegrade wire escalation strategy

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.

Group Type: OTHER

CTO PCI without the first-choice Gladius guidewire

Intervention Type: PROCEDURE

CTO PCI using standard antegrade wire escalation strategy

Interventions

CTO PCI with the first-choice Gladius guidewire

CTO PCI using antegrade wiring strategy with the first-choice Gladius guidewire

Intervention Type: PROCEDURE

CTO PCI without the first-choice Gladius guidewire

CTO PCI using standard antegrade wire escalation strategy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Cardiology, Warsaw, Poland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Institute of Cardiology

Warsaw, , Poland

Countries

Poland

Other Identifiers

2.59/III/20

Identifier Type: -

Identifier Source: org_study_id