Coronary Artery Disease, Coronary Occlusion, Percutaneous Coronary Intervention
Conditions
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.
Interventions
PROCEDURECTO PCI with the first-choice Gladius guidewire
CTO PCI using antegrade wiring strategy with the first-choice Gladius guidewire
PROCEDURECTO PCI without the first-choice Gladius guidewire
CTO PCI using standard antegrade wire escalation strategy
Sponsors
National Institute of Cardiology, Warsaw, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time-efficiency of antegrade wiring strategy | during procedure (intraprocedural) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time-efficiency of successful antegrade approach | during procedure (intraprocedural) | 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-efficiency of antegrade approach | during procedure (intraprocedural) | 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-efficiency of successful CTO recanalization using any technique | during procedure (intraprocedural) | 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) |
| total procedural time | during procedure (intraprocedural) | total procedural time defined as the time from getting arterial access to the time of removal of the arterial sheaths |
| successful guidewire crossing through CTO using antegrade wiring strategy | during procedure (intraprocedural) | successful guidewire crossing through CTO using antegrade wiring strategy |
| successful guidewire crossing through CTO with restoration of flow using antegrade wiring strategy | during procedure (intraprocedural) | successful guidewire crossing through CTO with restoration of flow (\<50% residual stenosis and TIMI flow grade 3) using antegrade wiring strategy |
| 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 using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies) |
| time-efficiency of successful antegrade wiring strategy | during procedure (intraprocedural) | 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 |
| final procedural success defined as successful guidewire crossing through CTO with restoration of flow | during procedure (intraprocedural) | final procedural success defined as successful guidewire crossing through CTO with restoration of flow (\<50% residual stenosis and TIMI flow grade 3) |
| contrast volume related to successful guidewire crossing through CTO using antegrade wiring strategy | during procedure (intraprocedural) | contrast volume related to successful guidewire crossing through CTO using antegrade wiring strategy |
| total contrast volume | during procedure (intraprocedural) | total contrast volume |
| radiation dose related to successful guidewire crossing through CTO using antegrade wiring strategy | during procedure (intraprocedural) | radiation dose related to successful guidewire crossing through CTO using antegrade wiring strategy |
| total radiation dose | during procedure (intraprocedural) | total radiation dose |
| incidence of periprocedural complications | during hospitalization (assessed up to 30 days) | incidence of periprocedural complications defined as: coronary perforation, tamponade, life-threatening arrhythmia requiring treatment, transient ischemic attack, stroke, myocardial infarction, urgent cardiac surgery, death |
| successful guidewire crossing through CTO with restoration of flow 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 (\<50% residual stenosis and TIMI flow grade 3) using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies) |
Countries
Poland
Outcome results
None listed