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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
CTO PCI using antegrade wiring strategy with the first-choice Gladius guidewire
CTO PCI using standard antegrade wire escalation strategy
National Institute of Cardiology
Warsaw, Poland
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
Time frame: during procedure (intraprocedural)
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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: during procedure (intraprocedural)
successful guidewire crossing through CTO using antegrade wiring strategy
successful guidewire crossing through CTO using antegrade wiring strategy
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: during procedure (intraprocedural)
total contrast volume
total contrast volume
Time frame: 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
Time frame: during procedure (intraprocedural)
total radiation dose
total radiation dose
Time frame: 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
Time frame: during hospitalization (assessed up to 30 days)
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