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RETRIEVE-AMI Study (RETRIEVE-AMI)

Primary Purpose

Myocardial Infarction, Thrombus, Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Retriever Thrombectomy
Percutaneous Coronary Intervention
Thrombus Aspiration
Sponsored by
Oxford University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial Infarction, Percutaneous coronary intervention, Stent Retriever, Thrombus Aspiration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary PCI patient with inferior ST elevation myocardial infarction (STEMI)
  • Right coronary culprit artery
  • TIMI 0 flow at presentation
  • Angiographic thrombus score ≥ 4
  • Occlusion prior to the crux
  • 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 > 6 h)
  • Class Killip III/IV and/or profound bradycardia (Heart rate < 40 bpm)
  • Known history of kidney failure
  • Ostial right coronary artery (RCA) occlusion
  • Highly tortuous vessel
  • Highly calcified vessel
  • Suspected (angiographically) spontaneous coronary artery dissection
  • Stent thrombosis
  • Previous stent implanted in the RCA proximally to the occlusion site
  • Previous coronary artery bypass graft surgery (CABG)
  • Previous STEMI/Transient Ischemic Attack/Stroke
  • Known anaemia (Hemoglobin <9)

Sites / Locations

  • Oxford Heart CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Standalone Percutaneous Coronary Intervention

Percutaneous Coronary Intervention and Thrombus Aspiration

Percutaneous Coronary Intervention and Retriever Thrombectomy

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

Thrombus volume (mm3)
Assessed with Optical Coherence Tomography [OCT]
Device-related target vessel complications
Assessed with angiography and/or OCT
Device deficiency
Assessed with angiography and/or OCT
Major adverse cardiac and cerebrovascular events (MACCE)
MACCE

Secondary Outcome Measures

Thrombus area (mm2)
Assessed with OCT
Flow area (mm2)
Assessed with OCT
Thromboatheroma area (mm2)
Assessed with OCT
Flow area (mm2)
Assessed with OCT
Stent expansion & apposition
Assessed with OCT
Thrombolysis in Myocardial Infarction (TIMI) flow
Assessed with angiography
Myocardial Blush Grade
Assessed with angiography
Angiography derived coronary physiology indices
Assessed with angiography

Full Information

First Posted
March 2, 2022
Last Updated
May 22, 2023
Sponsor
Oxford University Hospitals NHS Trust
Collaborators
Medtronic, Terumo Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05307965
Brief Title
RETRIEVE-AMI Study
Acronym
RETRIEVE-AMI
Official Title
Stent Retriever Thrombectomy for Thrombus Burden Reduction in Patients With Acute Myocardial Infarction - RETRIEVE-AMI Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oxford University Hospitals NHS Trust
Collaborators
Medtronic, Terumo Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Thrombus, Coronary Artery Disease
Keywords
Myocardial Infarction, Percutaneous coronary intervention, Stent Retriever, Thrombus Aspiration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standalone Percutaneous Coronary Intervention
Arm Type
Active Comparator
Arm 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.
Arm Title
Percutaneous Coronary Intervention and Thrombus Aspiration
Arm Type
Active Comparator
Arm 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.
Arm Title
Percutaneous Coronary Intervention and Retriever Thrombectomy
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Retriever Thrombectomy
Other Intervention Name(s)
SolitaireTM X Revascularisation Device, Stent Retriever
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention
Intervention Description
Standard of care
Intervention Type
Procedure
Intervention Name(s)
Thrombus Aspiration
Other Intervention Name(s)
Aspiration-assisted thrombectomy
Intervention Description
Standard of care treatment with manual thrombectomy catheter
Primary Outcome Measure Information:
Title
Thrombus volume (mm3)
Description
Assessed with Optical Coherence Tomography [OCT]
Time Frame
Pre-stent implantation during PCI
Title
Device-related target vessel complications
Description
Assessed with angiography and/or OCT
Time Frame
Pre-stent implantation during PCI
Title
Device deficiency
Description
Assessed with angiography and/or OCT
Time Frame
Pre-stent implantation during PCI
Title
Major adverse cardiac and cerebrovascular events (MACCE)
Time Frame
Up to 30 days after PCI
Title
MACCE
Time Frame
At 6 months after PCI
Secondary Outcome Measure Information:
Title
Thrombus area (mm2)
Description
Assessed with OCT
Time Frame
Pre-stent implantation during PCI
Title
Flow area (mm2)
Description
Assessed with OCT
Time Frame
Pre-stent implantation during PCI
Title
Thromboatheroma area (mm2)
Description
Assessed with OCT
Time Frame
Post-stent implantation during PCI
Title
Flow area (mm2)
Description
Assessed with OCT
Time Frame
Post-stent implantation during PCI
Title
Stent expansion & apposition
Description
Assessed with OCT
Time Frame
Post-stent implantation during PCI
Title
Thrombolysis in Myocardial Infarction (TIMI) flow
Description
Assessed with angiography
Time Frame
Post-stent implantation during PCI
Title
Myocardial Blush Grade
Description
Assessed with angiography
Time Frame
Post-stent implantation during PCI
Title
Angiography derived coronary physiology indices
Description
Assessed with angiography
Time Frame
Post-stent implantation during PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary PCI patient with ST elevation myocardial infarction (STEMI) TIMI 0 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 > 6 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanni Luigi De Maria, MD PhD
Phone
00441865228364
Email
GiovanniLuigi.DeMaria@ouh.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Luigi De Maria
Organizational Affiliation
Oxford University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford Heart Centre
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni L De Maria, MD
First Name & Middle Initial & Last Name & Degree
Giovanni L De Maria, MD PhD
First Name & Middle Initial & Last Name & Degree
Adrian P Banning, MD
First Name & Middle Initial & Last Name & Degree
Keith M Channon, MBChB PhD
First Name & Middle Initial & Last Name & Degree
Jeremy P Langrish, MB BCh PhD
First Name & Middle Initial & Last Name & Degree
Rafail A Kotronias, MBChB MSc

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD available to other researchers unless requested and upon the discretion of the Chief Investigator
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