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Completed

NCT Number: NCT05307965

RETRIEVE-AMI Study

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.

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Key information

Conditions

Myocardial Infarction Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Embolism and Thrombosis Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Thrombus Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oxford Heart Centre

Oxford, OX3 9DU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Retriever Thrombectomy

Device

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.

Other names: SolitaireTM X Revascularisation Device, Stent Retriever

Percutaneous coronary intervention

Procedure

Standard of care

Thrombus Aspiration

Procedure

Standard of care treatment with manual thrombectomy catheter

Other names: Aspiration-assisted thrombectomy

Primary outcomes

  1. Thrombus Volume (mm^3)

    Time frame: During PCI prior to stent implantation (typically 30 min from start of procedure)

    Assessed with Optical Coherence Tomography [OCT]

  2. Device-related Target Vessel Complications

    Time frame: During PCI prior to stent implantation (typically 30 min from start of procedure)

    Assessed with angiography and/or OCT

  3. Device Deficiency

    Time frame: During PCI prior to stent implantation (typically 30 min from start of procedure)

    Assessed with angiography and/or OCT

  4. Major Adverse Cardiac and Cerebrovascular Events (MACCE)

    Time frame: Up to 30 days after PCI

  5. MACCE

    Time frame: At 6 months after PCI

Secondary outcomes

  1. Flow Volume (mm^3)

    Time frame: During PCI prior to stent implantation (typically 30 min from start of procedure)

    Assessed with OCT

  2. Thromboatheroma Volume (mm^3)

    Time frame: Post-stent implantation during PCI (typically 50 min after procedure start)

    Assessed with OCT

  3. Flow Volume (mm^3)

    Time frame: Post-stent implantation during PCI (typically 50 min after procedure start)

    Assessed with OCT

  4. Number of Participants With Stent Underexpansion & Malapposition

    Time frame: Post-stent implantation during PCI (typically 50 min after procedure start)

    Assessed with OCT according to established international consensus criteria.

  5. Thrombolysis in Myocardial Infarction (TIMI) Flow

    Time frame: Post-stent implantation during PCI (typically 60 min after procedure start)

    Assessed with angiography according to the TIMI Flow criteria

  6. Number of Participants With Myocardial Blush Grade (MBG) < 3

    Time frame: Post-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.

  7. Angiograpicy Derived Index of Microcirculatory Resistance

    Time frame: Post-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.

Sponsors and collaborators

Lead sponsor

Oxford University Hospitals NHS Trust

Other

Collaborators

  • Medtronic
  • Terumo Corporation

Registry information

Official study title

Stent Retriever Thrombectomy for Thrombus Burden Reduction in Patients With Acute Myocardial Infarction - RETRIEVE-AMI Study

Acronym: RETRIEVE-AMI

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Apr 1, 2022
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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