Clinical trial NCT04691778: Coronary CTO PCI Using Antegrade Wiring Strategy With a First-choice Gladius Guidewire (Gladius First)
Official title: Coronary Chronic Total Occlusion Percutaneous Coronary Intervention Using Antegrade Wiring Strategy With a First-choice Gladius Guidewire: a Randomized Clinical Study (Gladius First Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Coronary Occlusion
Percutaneous Coronary Intervention
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: time-efficiency of antegrade wiring strategy
timeFrame: during procedure (intraprocedural)
Secondary outcomes:
measure: time-efficiency of successful antegrade wiring strategy
timeFrame: during procedure (intraprocedural)
measure: time-efficiency of successful antegrade approach
timeFrame: during procedure (intraprocedural)
measure: time-efficiency of antegrade approach
timeFrame: during procedure (intraprocedural)
measure: time-efficiency of successful CTO recanalization using any technique
timeFrame: during procedure (intraprocedural)
measure: total procedural time
timeFrame: during procedure (intraprocedural)
measure: successful guidewire crossing through CTO using antegrade wiring strategy
timeFrame: during procedure (intraprocedural)
measure: successful guidewire crossing through CTO with restoration of flow using antegrade wiring strategy
timeFrame: during procedure (intraprocedural)
measure: successful guidewire crossing through CTO using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)
timeFrame: during procedure (intraprocedural)
measure: successful guidewire crossing through CTO with restoration of flow using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)
timeFrame: during procedure (intraprocedural)
measure: final procedural success defined as successful guidewire crossing through CTO with restoration of flow
timeFrame: during procedure (intraprocedural)
measure: contrast volume related to successful guidewire crossing through CTO using antegrade wiring strategy
timeFrame: during procedure (intraprocedural)
measure: total contrast volume
timeFrame: during procedure (intraprocedural)
measure: radiation dose related to successful guidewire crossing through CTO using antegrade wiring strategy
timeFrame: during procedure (intraprocedural)
measure: total radiation dose
timeFrame: during procedure (intraprocedural)
measure: incidence of periprocedural complications
timeFrame: during hospitalization (assessed up to 30 days)
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: National Institute of Cardiology
Study officials:
References: