Polish Institute of Cardiology started a clinical trial of Coronary CTO PCI Using Antegrade Wiring Strategy With a First-choice Gladius Guidewire
Institute of Cardiology, Warsaw, Poland is conducting the clinical trial Coronary CTO PCI Using Antegrade Wiring Strategy With a First-choice Gladius Guidewire (Gladius First).
The Gladius First trial is designed as a 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.
Actual study start date is December 8, 2020. The researchers expect to complete the study by April 1, 2022.
One primary outcome measure is 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.
Among the exclusion criteria are:
- 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
The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04691778) Warsaw, Poland.
