RETRIEVE-AMI Study

NHS Trust

Status: Completed

Conditions: Coronary Artery Disease; Myocardial Infarction; Thrombus

Treatments: Device: Retriever Thrombectomy; Procedure: Thrombus Aspiration; Procedure: Percutaneous Coronary Intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05307965

15488

Details and patient eligibility

About

Heart attacks are caused by the sudden formation of a clot inside a diseased coronary artery which reduces blood flow beyond the blockage site. During conventional treatment of the blockage with what is known as a stent; a stainless steel tub that keeps the artery open, the clot that has formed is disrupted and is pushed further down leading to damage in smaller blood vessels supplying the heart muscle. This additional damage can lead to long-term heart muscle damage influencing recovery and wellbeing. The original concept that was tested to prevent this 'clot shower' was that of a suction device to withdraw the clot before stenting. However, this approach has not translated to patient benefit. Amongst the reasons put forward for the inefficacy of the suction device was that it does not remove the entire clot as it does not interact with it. A new device that physically interacts with the clot and traps it before pulling it out - the stent retriever - is now routinely used in stroke therapy to remove clots in the arteries supplying the brain. This device has been successfully used as a last resort to remove clots in a small number of heart attacks. The investigators hypothesize that stent retriever therapy will be more effective in clot removal than the current standard of care; suction or stenting. To study this, the investigators propose the RETRIEVE-AMI randomised controlled trial.

Enrollment: 81 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary PCI patient with ST elevation myocardial infarction (STEMI)
• 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

• Female participant who is pregnant or lactating
• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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81 participants in 3 patient groups

Standalone Percutaneous Coronary Intervention

Active Comparator group

Description:

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.

Treatment:

Procedure: Percutaneous Coronary Intervention

Percutaneous Coronary Intervention and Thrombus Aspiration

Active Comparator group

Description:

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.

Treatment:

Procedure: Percutaneous Coronary Intervention

Procedure: Thrombus Aspiration

Percutaneous Coronary Intervention and Retriever Thrombectomy

Experimental group

Description:

Participants randomised to the stent-retriever thrombectomy arm of the RETRIEVE AMI trial will undergo stent-retriever thrombectomy with the SolitaireTM X Revascularisation Device.

Treatment:

Procedure: Percutaneous Coronary Intervention

Device: Retriever Thrombectomy