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

October 3, 2024 updated by: National Institute of Cardiology, Warsaw, Poland

Coronary Chronic Total Occlusion Percutaneous Coronary Intervention Using Antegrade Wiring Strategy With a First-choice Gladius Guidewire: a Randomized Clinical Study (Gladius First Trial)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Maksymilian P. Opolski, MD, PhD
  • Phone Number: +48501444303
  • Email: mopolski@ikard.pl

Study Locations

  • Poland
      • Warsaw, Poland, 04-628
        • National Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: CTO PCI using antegrade wiring strategy starting with the Gladius guidewire
Study subjects will undergo CTO PCI with primary antegrade wiring strategy starting with the Gladius guidewire. In case of failed CTO crossing with the Gladius wire, the decision on continuing antegrade wire escalation with a different wire or switching to a different CTO PCI strategy will be left to the discretion of the operator.
Procedure: CTO PCI with the first-choice Gladius guidewire
CTO PCI using antegrade wiring strategy with the first-choice Gladius guidewire
Other: CTO PCI using standard antegrade wire escalation strategy
Control subjects will undergo CTO PCI using standard antegrade wiring strategy starting with the lower/intermediate penetration force guidewires and, if necessary, escalating up to high gram-force guidewires, but without the use of first-choice Gladius guidewire.
Procedure: CTO PCI without the first-choice Gladius guidewire
CTO PCI using standard antegrade wire escalation strategy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
during procedure (intraprocedural)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
during procedure (intraprocedural)
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
during procedure (intraprocedural)
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
during procedure (intraprocedural)
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)
during procedure (intraprocedural)
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
during procedure (intraprocedural)
successful guidewire crossing through CTO using antegrade wiring strategy
Time Frame: during procedure (intraprocedural)
successful guidewire crossing through CTO using antegrade wiring strategy
during procedure (intraprocedural)
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
during procedure (intraprocedural)
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)
during procedure (intraprocedural)
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)
during procedure (intraprocedural)
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)
during procedure (intraprocedural)
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
during procedure (intraprocedural)
total contrast volume
Time Frame: during procedure (intraprocedural)
total contrast volume
during procedure (intraprocedural)
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
during procedure (intraprocedural)
total radiation dose
Time Frame: during procedure (intraprocedural)
total radiation dose
during procedure (intraprocedural)
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
during hospitalization (assessed up to 30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Cardiology, Warsaw, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2.59/III/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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