Study Results
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View full resultsBasic Information
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COMPLETED
NA
81 participants
INTERVENTIONAL
2022-05-06
2025-05-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standalone Percutaneous Coronary Intervention
Participants will have standard of care treatment. They will undergo PCI with devices and techniques driven by clinical decision making at the patient level and institutional level, and carried out in accordance with the Oxford University Hospitals NHS Foundation Trust department guidelines.
Percutaneous Coronary Intervention
Standard of care
Percutaneous Coronary Intervention and Thrombus Aspiration
Participants will have standard of care treatment with manual thrombectomy catheter and PCI. They will undergo PCI with devices and techniques driven by clinical decision making at the patient level and institutional level, and carried out in accordance with the Oxford University Hospitals NHS Foundation Trust department guidelines.
Percutaneous Coronary Intervention
Standard of care
Thrombus Aspiration
Standard of care treatment with manual thrombectomy catheter
Percutaneous Coronary Intervention and Retriever Thrombectomy
Participants randomised to the stent-retriever thrombectomy arm of the RETRIEVE AMI trial will undergo stent-retriever thrombectomy with the SolitaireTM X Revascularisation Device.
Retriever Thrombectomy
The SolitaireTM X revascularisation device is a self-expanding stent designed for dynamic clot integration with radiopaque markers that enhance visualisation of the optimal working length. After a thrombotic occlusion has been identified and crossed with a guidewire, the stent-retriever thrombectomy proceeds. A microcatheter (e.g., PhenomTM, MarksmanTM) is advanced over the guidewire and once it has traversed the thrombotic occlusion, the SolitaireTM X device is advanced through the microcatheter until the usable length of the stent extends past each side of the thrombus in the vessel. As the microcatheter is retracted to the proximal radiopaque marker of the stent, the stent self-expands and entangles the thrombus. The microcatheter and SolitaireTM X Revascularisation Device are withdrawn as a unit into the guide catheter under continuous aspiration. PCI then proceeds driven by clinical decision making and department guidelines.
Percutaneous Coronary Intervention
Standard of care
Interventions
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Retriever Thrombectomy
The SolitaireTM X revascularisation device is a self-expanding stent designed for dynamic clot integration with radiopaque markers that enhance visualisation of the optimal working length. After a thrombotic occlusion has been identified and crossed with a guidewire, the stent-retriever thrombectomy proceeds. A microcatheter (e.g., PhenomTM, MarksmanTM) is advanced over the guidewire and once it has traversed the thrombotic occlusion, the SolitaireTM X device is advanced through the microcatheter until the usable length of the stent extends past each side of the thrombus in the vessel. As the microcatheter is retracted to the proximal radiopaque marker of the stent, the stent self-expands and entangles the thrombus. The microcatheter and SolitaireTM X Revascularisation Device are withdrawn as a unit into the guide catheter under continuous aspiration. PCI then proceeds driven by clinical decision making and department guidelines.
Percutaneous Coronary Intervention
Standard of care
Thrombus Aspiration
Standard of care treatment with manual thrombectomy catheter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* TIMI 0/1 flow at presentation
* Angiographic thrombus score ≥ 4
* Vessel diameter at site of occlusion ≥ 3.0 mm (measured by quantitative coronary angiography)
Exclusion Criteria
* Participant with known hypersensitivity to nickel-titanium
* Unconscious at presentation
* Late presenter (pain to wire time \> 12 h)
* Class Killip III/IV and/or profound bradycardia (Heart rate \< 40 bpm)
* Known history of kidney failure
* Ostial occlusion
* Highly tortuous vessel
* Highly calcified vessel
* Suspected (angiographically) spontaneous coronary artery dissection
* Stent thrombosis
* Previous stent implanted proximal to the occlusion site
* Previous coronary artery bypass graft surgery (CABG)
* Previous STEMI/Transient Ischemic Attack/Stroke
* Known anaemia (Hemoglobin \<9)
18 Years
90 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Terumo Corporation
INDUSTRY
Oxford University Hospitals NHS Trust
OTHER
Responsible Party
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Giovanni Luigi De Maria
Primary Investigator
Principal Investigators
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Giovanni Luigi De Maria
Role: PRINCIPAL_INVESTIGATOR
Oxford University Hospitals NHS Trust
Locations
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Oxford Heart Centre
Oxford, , United Kingdom
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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15488
Identifier Type: -
Identifier Source: org_study_id
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