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Clinical Trials/NCT05307965
NCT05307965
Completed
Not Applicable

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

Oxford University Hospitals NHS Trust1 site in 1 country81 target enrollmentMay 6, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocardial Infarction
Sponsor
Oxford University Hospitals NHS Trust
Enrollment
81
Locations
1
Primary Endpoint
Thrombus Volume (mm^3)
Status
Completed
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 6, 2022
End Date
May 28, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Giovanni Luigi De Maria

Primary Investigator

Oxford University Hospitals NHS Trust

Eligibility Criteria

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

Outcomes

Primary Outcomes

Thrombus Volume (mm^3)

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

Assessed with Optical Coherence Tomography \[OCT\]

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

Device Deficiency

Time Frame: During 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)

Time Frame: Up to 30 days after PCI

MACCE

Time Frame: At 6 months after PCI

Secondary Outcomes

  • Flow Volume (mm^3)(Post-stent implantation during PCI (typically 50 min after procedure start))
  • Thromboatheroma 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))
  • Number of Participants With Myocardial Blush Grade (MBG) < 3(Post-stent implantation during PCI (typically 60 min after procedure start))
  • Angiograpicy Derived Index of Microcirculatory Resistance(Post-stent implantation during PCI (typically 60 min after procedure start))

Study Sites (1)

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