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

Coronary Artery Disease Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04691778
• Other study ID #: 2.59/III/20
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: February 2024
• Source: National Institute of Cardiology, Warsaw, Poland
• Contact: Maksymilian P. Opolski, MD, PhD
• Phone: +48501444303
• Email: mopolski[@]ikard.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 1, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Occlusion
• Percutaneous Coronary Intervention

Intervention

Procedure:
• CTO PCI with the first-choice Gladius guidewire
CTO PCI using antegrade wiring strategy with the first-choice Gladius guidewire
• CTO PCI without the first-choice Gladius guidewire
CTO PCI using standard antegrade wire escalation strategy

Locations

Country	Name	City	State
Poland	National Institute of Cardiology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	successful guidewire crossing through CTO using antegrade wiring strategy	successful guidewire crossing through CTO using antegrade wiring strategy	during procedure (intraprocedural)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	total contrast volume	total contrast volume	during procedure (intraprocedural)
Secondary	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)
Secondary	total radiation dose	total radiation dose	during procedure (intraprocedural)
Secondary	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)