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Completed

NCT Number: NCT04691778

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 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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Coronary Occlusion Heart Diseases Myocardial Ischemia Percutaneous Coronary Intervention Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Cardiology

Warsaw, 04-628, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CTO PCI with the first-choice Gladius guidewire

Procedure

CTO PCI using antegrade wiring strategy with the first-choice Gladius guidewire

CTO PCI without the first-choice Gladius guidewire

Procedure

CTO PCI using standard antegrade wire escalation strategy

Primary outcomes

  1. time-efficiency of antegrade wiring strategy

    Time frame: 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 outcomes

  1. time-efficiency of successful antegrade wiring strategy

    Time frame: 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

  2. time-efficiency of successful antegrade approach

    Time frame: 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

  3. time-efficiency of antegrade approach

    Time frame: 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

  4. time-efficiency of successful CTO recanalization using any technique

    Time frame: 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)

  5. total procedural time

    Time frame: during procedure (intraprocedural)

    total procedural time defined as the time from getting arterial access to the time of removal of the arterial sheaths

  6. successful guidewire crossing through CTO using antegrade wiring strategy

    Time frame: during procedure (intraprocedural)

    successful guidewire crossing through CTO using antegrade wiring strategy

  7. successful guidewire crossing through CTO with restoration of flow using antegrade wiring strategy

    Time frame: during procedure (intraprocedural)

    successful guidewire crossing through CTO with restoration of flow (<50% residual stenosis and TIMI flow grade 3) using antegrade wiring strategy

  8. successful guidewire crossing through CTO using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)

    Time frame: during procedure (intraprocedural)

    successful guidewire crossing through CTO using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)

  9. successful guidewire crossing through CTO with restoration of flow using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)

    Time frame: 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)

  10. final procedural success defined as successful guidewire crossing through CTO with restoration of flow

    Time frame: 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)

  11. contrast volume related to successful guidewire crossing through CTO using antegrade wiring strategy

    Time frame: during procedure (intraprocedural)

    contrast volume related to successful guidewire crossing through CTO using antegrade wiring strategy

  12. total contrast volume

    Time frame: during procedure (intraprocedural)

    total contrast volume

  13. radiation dose related to successful guidewire crossing through CTO using antegrade wiring strategy

    Time frame: during procedure (intraprocedural)

    radiation dose related to successful guidewire crossing through CTO using antegrade wiring strategy

  14. total radiation dose

    Time frame: during procedure (intraprocedural)

    total radiation dose

  15. incidence of periprocedural complications

    Time frame: 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

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Warsaw, Poland

Other

Registry information

Official study 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)

Acronym: Gladius First

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Dec 31, 2020
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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