NCT04691778Completed
Coronary CTO PCI Using Antegrade Wiring Strategy With a First-choice Gladius Guidewire (Gladius First)
Coronary Chronic Total Occlusion Percutaneous Coronary Intervention Using Antegrade Wiring Strategy With a First-choice Gladius Guidewire: a Randomized Clinical Study (Gladius First Trial)
Source: ClinicalTrials.gov · Last updated 8 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 69 (actual)
- First submitted
- 18 Dec 2020
- Start date
- 1 Jan 2021
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Diseases
- Coronary artery disease
- NCT number
- NCT04691778
What you commit to
- Study type: Interventional
- Participants enrolled: 69
- From 1 Jan 2021 to the primary completion date, 30 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- prior myocardial infarction within 4 weeks before study enrolment
- contraindication to antiplatelet therapy and/or heparin
Other illness
- unstable angina and/or myocardial infarction
- severe inflammatory disease
Lab values
- chronic kidney disease (defined as eGFR ≤30 ml/min/m2)
Other
- in-stent CTO
- 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
- positive pregnancy test or breast-feeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institute of Cardiology Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.