RETRIEVE-AMI Study

NCT05307965 | Completed Results DMC

• 1 other identifier: 15488
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Thrombus; Coronary Artery Disease

Keywords

Myocardial Infarction; Percutaneous coronary intervention; Stent Retriever; Thrombus Aspiration

Outcome Measures

Primary Outcomes (5)

• Thrombus Volume (mm^3)

  Assessed with Optical Coherence Tomography \[OCT\]

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

• Device-related Target Vessel Complications

  Assessed with angiography and/or OCT

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

• Device Deficiency

  Assessed with angiography and/or OCT

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

• Major Adverse Cardiac and Cerebrovascular Events (MACCE)

  Up to 30 days after PCI

• MACCE

  At 6 months after PCI

Secondary Outcomes (7)

• Flow Volume (mm^3)

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

• Thromboatheroma Volume (mm^3)

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

• Flow Volume (mm^3)

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

• Number of Participants With Stent Underexpansion & Malapposition

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

• Thrombolysis in Myocardial Infarction (TIMI) Flow

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

Study Arms (3)

Standalone Percutaneous Coronary Intervention

ACTIVE COMPARATOR

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.

Procedure: Percutaneous Coronary Intervention

Percutaneous Coronary Intervention and Thrombus Aspiration

ACTIVE COMPARATOR

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.

Procedure: Percutaneous Coronary Intervention; Procedure: Thrombus Aspiration

Percutaneous Coronary Intervention and Retriever Thrombectomy

EXPERIMENTAL

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

Device: Retriever Thrombectomy; Procedure: Percutaneous Coronary Intervention

Interventions

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.

Also known as: SolitaireTM X Revascularisation Device, Stent Retriever

Percutaneous Coronary Intervention and Retriever Thrombectomy

Percutaneous Coronary Intervention PROCEDURE

Standard of care

Percutaneous Coronary Intervention and Retriever Thrombectomy; Percutaneous Coronary Intervention and Thrombus Aspiration; Standalone Percutaneous Coronary Intervention

Thrombus Aspiration PROCEDURE

Standard of care treatment with manual thrombectomy catheter

Also known as: Aspiration-assisted thrombectomy

Percutaneous Coronary Intervention and Thrombus Aspiration

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• Medtronic: collaborator
• Terumo Corporation: collaborator

Study Sites (1)

Oxford Heart Centre

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (30)

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MeSH Terms

Conditions

Myocardial Infarction; Thrombosis; Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Giovanni Luigi De Maria
• Organization: John Radcliffe Hospital

GiovanniLuigi.DeMaria@ouh.nhs.uk

+441865228364

Study Officials

• Giovanni Luigi De Maria

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the interventional nature of the trial, masking is not feasible for operators, the clinical care team and participants. However, analysis of the OCT-derived primary and secondary end-points will be conducted offline in a blinded fashion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: The study will consist of 3 arms. Eligible participants will be 1:1:1 randomised to receive either standalone percutaneous coronary intervention (PCI) (Arm 1), thrombus aspiration + PCI (Arm 2) or retriever thrombectomy + PCI (Arm 3).

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: April 1, 2022
• Study Start: May 6, 2022
• Primary Completion: October 24, 2024
• Study Completion: May 28, 2025
• Last Updated: September 5, 2025
• Results First Posted: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)