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COMPLETEDNANCT04691778

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

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 co...

Lead sponsor: National Institute of Cardiology, Warsaw, Poland•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

National Institute of Cardiology, Warsaw, Poland

Age

18 - No limit years

Sex

ALL

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 8, 2024Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment69

Start dateJan 2021

Last updatedOct 8, 2024

Condition

Coronary Artery Disease Coronary Occlusion Percutaneous Coronary Intervention

Locations shown

National Institute of Cardiology

Warsaw

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 8, 2024Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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