MedPath

RETRIEVE-AMI Study

Not Applicable
Completed
Conditions
Myocardial Infarction
Thrombus
Coronary Artery Disease
Registration Number
NCT05307965
Lead Sponsor
Oxford University Hospitals NHS Trust
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
81
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Thrombus Volume (mm^3)During PCI prior to stent implantation (typically 30 min from start of procedure)

Assessed with Optical Coherence Tomography \[OCT\]

Device-related Target Vessel ComplicationsDuring PCI prior to stent implantation (typically 30 min from start of procedure)

Assessed with angiography and/or OCT

Device DeficiencyDuring PCI prior to stent implantation (typically 30 min from start of procedure)

Assessed with angiography and/or OCT

Major Adverse Cardiac and Cerebrovascular Events (MACCE)Up to 30 days after PCI
MACCEAt 6 months after PCI
Secondary Outcome Measures
NameTimeMethod
Flow Volume (mm^3)Post-stent implantation during PCI (typically 50 min after procedure start)

Assessed with OCT

Thromboatheroma Volume (mm^3)Post-stent implantation during PCI (typically 50 min after procedure start)

Assessed with OCT

Number of Participants With Stent Underexpansion & MalappositionPost-stent implantation during PCI (typically 50 min after procedure start)

Assessed with OCT according to established international consensus criteria.

Thrombolysis in Myocardial Infarction (TIMI) FlowPost-stent implantation during PCI (typically 60 min after procedure start)

Assessed with angiography according to the TIMI Flow criteria

Number of Participants With Myocardial Blush Grade (MBG) < 3Post-stent implantation during PCI (typically 60 min after procedure start)

Assessed angiographically according to the TIMI Myocardial Blush Grade Score Criteria. The scale goes from 0-3. Myocardial blush grade (MGB) of 0, 1 and 2 indicates angiographic malperfusion, whilst a Myocardial blush grade (MGB) score of 3 indicates normal perfusion.

Angiograpicy Derived Index of Microcirculatory ResistancePost-stent implantation during PCI (typically 60 min after procedure start)

The angiography derived index of microcirculatory resistance is a continuous variable that measures microcirculatory resistance. No formal minimum and maximum values exist. The higher the value, the worse the angiographic perfusion. A value over 40U confers an adverse prognosis.

Trial Locations

Locations (1)

Oxford Heart Centre

🇬🇧

Oxford, United Kingdom

Oxford Heart Centre
🇬🇧Oxford, United Kingdom

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.