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

NCT04691778 | Completed

• 1 other identifier: 2.59/III/20
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• time-efficiency of antegrade wiring strategy

  time-efficiency of antegrade wiring strategy defined as the time from advancement of the first wire into the proximal cap to either the time of successful antegrade wiring through the lesion or the time of cessation of antegrade wiring and changing CTO PCI strategy according to the hybrid algorithm

  during procedure (intraprocedural)

Secondary Outcomes (15)

• time-efficiency of successful antegrade wiring strategy

  during procedure (intraprocedural)

• time-efficiency of successful antegrade approach

  during procedure (intraprocedural)

• time-efficiency of antegrade approach

  during procedure (intraprocedural)

• time-efficiency of successful CTO recanalization using any technique

  during procedure (intraprocedural)

• total procedural time

  during procedure (intraprocedural)

Study Arms (2)

CTO PCI using antegrade wiring strategy starting with the Gladius guidewire

ACTIVE COMPARATOR

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.

Procedure: CTO PCI with the first-choice Gladius guidewire

CTO PCI using standard antegrade wire escalation strategy

OTHER

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.

Procedure: CTO PCI without the first-choice Gladius guidewire

Interventions

CTO PCI with the first-choice Gladius guidewire PROCEDURE

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

CTO PCI using antegrade wiring strategy starting with the Gladius guidewire

CTO PCI without the first-choice Gladius guidewire PROCEDURE

CTO PCI using standard antegrade wire escalation strategy

CTO PCI using standard antegrade wire escalation strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead

Study Sites (1)

National Institute of Cardiology

Warsaw, 04-628, Poland

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Occlusion

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 31, 2020
• Study Start: January 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: January 30, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)