Coronary Artery DiseaseGladius FirstNCT04691778
Coronary CTO PCI Using Antegrade Wiring Strategy With a First-choice Gladius Guidewire (Gladius First)
A study testing CTO PCI with the first-choice Gladius guidewire and CTO PCI without the first-choice Gladius guidewire in people with Coronary Artery Disease and Coronary Occlusion, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Occlusion, Percutaneous Coronary Intervention
- What is being tested?
- CTO PCI with the first-choice Gladius guidewire and CTO PCI without the first-choice Gladius guidewire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2021to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- contraindication to antiplatelet therapy and/or heparin
- severe inflammatory disease
- positive pregnancy test or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Being tested
- CTO PCI with the first-choice Gladius guidewire, CTO PCI without the first-choice Gladius guidewire
- Medical subject headings
- Coronary Artery Disease, Coronary Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTO PCI with the first-choice Gladius guidewireProcedure or surgery
CTO PCI using antegrade wiring strategy with the first-choice Gladius guidewire
CTO PCI without the first-choice Gladius guidewireProcedure or surgery
CTO PCI using standard antegrade wire escalation strategy
| Study group | Role | What they receive |
|---|---|---|
| CTO PCI using antegrade wiring strategy starting with the Gladius guidewire | Active comparator | 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. Receives: Procedure: CTO PCI with the first-choice Gladius guidewire |
| CTO PCI using standard antegrade wire escalation strategy | Other | 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. Receives: Procedure: CTO PCI without the first-choice Gladius guidewire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during procedure (intraprocedural)
Secondary outcomes (15)
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
Measured: during procedure (intraprocedural)
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
Measured: during procedure (intraprocedural)
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
Measured: during procedure (intraprocedural)
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)
Measured: during procedure (intraprocedural)
total procedural time
total procedural time defined as the time from getting arterial access to the time of removal of the arterial sheaths
Measured: during procedure (intraprocedural)
successful guidewire crossing through CTO using antegrade wiring strategy
successful guidewire crossing through CTO using antegrade wiring strategy
Measured: during procedure (intraprocedural)
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
Measured: during procedure (intraprocedural)
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)
Measured: 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)
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)
Measured: during procedure (intraprocedural)
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)
Measured: during procedure (intraprocedural)
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
Measured: during procedure (intraprocedural)
total contrast volume
total contrast volume
Measured: during procedure (intraprocedural)
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
Measured: during procedure (intraprocedural)
total radiation dose
total radiation dose
Measured: during procedure (intraprocedural)
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
Measured: during hospitalization (assessed up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Jan 2021
- Primary completion30 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691778
- Sponsor's protocol ID
- 2.59/III/20
- Acronym
- Gladius First
- Status last verified
- Feb 2024
- First submitted
- 18 Dec 2020
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04691778
- Acronym / sponsor ID
- Gladius First / 2.59/III/20
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTO PCI using antegrade wiring strategy starting with the Gladius guidewire | Active comparator | Procedure: CTO PCI with the first-choice Gladius guidewireStudy 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. |
| CTO PCI using standard antegrade wire escalation strategy | Other | Procedure: CTO PCI without the first-choice Gladius guidewireControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTO PCI with the first-choice Gladius guidewireCTO PCI using antegrade wiring strategy with the first-choice Gladius guidewire | Procedure or surgery | CTO PCI using antegrade wiring strategy starting with the Gladius guidewire |
| CTO PCI without the first-choice Gladius guidewireCTO PCI using standard antegrade wire escalation strategy | Procedure or surgery | CTO PCI using standard antegrade wire escalation strategy |
Primary outcome
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
15 secondary outcomes
time-efficiency of successful antegrade wiring strategy
Time frame: during procedure (intraprocedural)
time-efficiency of successful antegrade approach
Time frame: during procedure (intraprocedural)
time-efficiency of antegrade approach
Time frame: during procedure (intraprocedural)
time-efficiency of successful CTO recanalization using any technique
Time frame: during procedure (intraprocedural)
total procedural time
Time frame: during procedure (intraprocedural)
successful guidewire crossing through CTO using antegrade wiring strategy
Time frame: 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 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 using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)
Time frame: during procedure (intraprocedural)
final procedural success defined as successful guidewire crossing through CTO with restoration of flow
Time frame: during procedure (intraprocedural)
contrast volume related to successful guidewire crossing through CTO using antegrade wiring strategy
Time frame: during procedure (intraprocedural)
total contrast volume
Time frame: during procedure (intraprocedural)
radiation dose related to successful guidewire crossing through CTO using antegrade wiring strategy
Time frame: during procedure (intraprocedural)
total radiation dose
Time frame: during procedure (intraprocedural)
incidence of periprocedural complications
Time frame: during hospitalization (assessed up to 30 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTO PCI with the first-choice Gladius guidewire and CTO PCI without the first-choice Gladius guidewire in people with Coronary Artery Disease and Coronary Occlusion, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time-efficiency of antegrade wiring strategy (time frame: during procedure (intraprocedural)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.