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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Coronary Occlusion
• Intervention / Treatment: Procedure: CTO PCI with the first-choice Gladius guidewire; Procedure: CTO PCI without the first-choice Gladius guidewire

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 04-628
    • National Institute of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: CTO PCI with the first-choice Gladius guidewire; CTO PCI using antegrade wiring strategy with the first-choice Gladius guidewire
Other: 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.	Procedure: CTO PCI without the first-choice Gladius guidewire; CTO PCI using standard antegrade wire escalation strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
time-efficiency of successful antegrade wiring strategy	time-efficiency of successful antegrade wiring strategy defined as the time from advancement of the first wire into the proximal cap to the time of successful antegrade wiring through the lesion	during procedure (intraprocedural)
time-efficiency of successful antegrade approach	time-efficiency of successful antegrade approach 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 successful antegrade dissection and re-entry strategy	during procedure (intraprocedural)
time-efficiency of antegrade approach	time-efficiency of antegrade approach defined as the time from advancement of the first wire into the proximal cap to either the time of successful antegrade wiring or antegrade dissection and re-entry strategy or the time of failed antegrade approach and changing CTO PCI strategy according to the hybrid algorithm	during procedure (intraprocedural)
time-efficiency of successful CTO recanalization using any technique	time-efficiency defined as the time from advancement of the first wire into the proximal cap to the time of successful CTO recanalization using any technique (including antegrade and retrograde strategies)	during procedure (intraprocedural)
total procedural time	total procedural time defined as the time from getting arterial access to the time of removal of the arterial sheaths	during procedure (intraprocedural)
successful guidewire crossing through CTO using antegrade wiring strategy	successful guidewire crossing through CTO using antegrade wiring strategy	during procedure (intraprocedural)
successful guidewire crossing through CTO with restoration of flow using antegrade wiring strategy	successful guidewire crossing through CTO with restoration of flow (<50% residual stenosis and TIMI flow grade 3) using antegrade wiring strategy	during procedure (intraprocedural)
successful guidewire crossing through CTO using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)	successful guidewire crossing through CTO using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)	during procedure (intraprocedural)
successful guidewire crossing through CTO with restoration of flow using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)	successful guidewire crossing through CTO with restoration of flow (<50% residual stenosis and TIMI flow grade 3) using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)	during procedure (intraprocedural)
final procedural success defined as successful guidewire crossing through CTO with restoration of flow	final procedural success defined as successful guidewire crossing through CTO with restoration of flow (<50% residual stenosis and TIMI flow grade 3)	during procedure (intraprocedural)
contrast volume related to successful guidewire crossing through CTO using antegrade wiring strategy	contrast volume related to successful guidewire crossing through CTO using antegrade wiring strategy	during procedure (intraprocedural)
total contrast volume	total contrast volume	during procedure (intraprocedural)
radiation dose related to successful guidewire crossing through CTO using antegrade wiring strategy	radiation dose related to successful guidewire crossing through CTO using antegrade wiring strategy	during procedure (intraprocedural)
total radiation dose	total radiation dose	during procedure (intraprocedural)
incidence of periprocedural complications	incidence of periprocedural complications defined as: coronary perforation, tamponade, life-threatening arrhythmia requiring treatment, transient ischemic attack, stroke, myocardial infarction, urgent cardiac surgery, death	during hospitalization (assessed up to 30 days)

Collaborators and Investigators

• Sponsor: National Institute of Cardiology, Warsaw, Poland

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Coronary Occlusion
• Other Study ID Numbers: 2.59/III/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No