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

Study Overview
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Brief Summary
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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.

Official Title
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Coronary Chronic Total Occlusion Percutaneous Coronary Intervention Using Antegrade Wiring Strategy With a First-choice Gladius Guidewire: a Randomized Clinical Study (Gladius First Trial)

Conditions
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Coronary Artery Disease, Coronary Occlusion, Percutaneous Coronary Intervention

Intervention / Treatment
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* Procedure: CTO PCI with the first-choice Gladius guidewire
* Procedure: CTO PCI without the first-choice Gladius guidewire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CTO PCI using antegrade wiring strategy starting with the Gladius guidewire<br>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<br>* CTO PCI using antegrade wiring strategy with the first-choice Gladius guidewire<br>|
| Other: CTO PCI using standard antegrade wire escalation strategy<br>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<br>* CTO PCI using standard antegrade wire escalation strategy<br>|

What is the study measuring?
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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) |