Trial Outcomes & Findings for RETRIEVE-AMI Study (NCT NCT05307965)
NCT ID: NCT05307965
Last Updated: 2025-09-05
Results Overview
Assessed with Optical Coherence Tomography \[OCT\]
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
During PCI prior to stent implantation (typically 30 min from start of procedure)
Results posted on
2025-09-05
Participant Flow
Participant milestones
| Measure |
Standalone Percutaneous Coronary Intervention
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.
Percutaneous Coronary Intervention: Standard of care
|
Percutaneous Coronary Intervention and Thrombus Aspiration
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.
Percutaneous Coronary Intervention: Standard of care
Thrombus Aspiration: Standard of care treatment with manual thrombectomy catheter
|
Percutaneous Coronary Intervention and Retriever Thrombectomy
Participants randomised to the stent-retriever thrombectomy arm of the RETRIEVE AMI trial will undergo stent-retriever thrombectomy with the SolitaireTM X Revascularisation Device.
Retriever Thrombectomy: 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 The microcatheter and SolitaireTM X Revascularisation Device are withdrawn as a unit into the guide catheter under continuous aspiration.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.
Percutaneous Coronary Intervention: Standard of care
|
|---|---|---|---|
|
At Randomisation
STARTED
|
27
|
27
|
27
|
|
At Randomisation
COMPLETED
|
27
|
26
|
27
|
|
At Randomisation
NOT COMPLETED
|
0
|
1
|
0
|
|
Flow Following Randomisation
STARTED
|
28
|
27
|
26
|
|
Flow Following Randomisation
COMPLETED
|
28
|
26
|
26
|
|
Flow Following Randomisation
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standalone Percutaneous Coronary Intervention
n=27 Participants
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.
Percutaneous Coronary Intervention: Standard of care
|
Percutaneous Coronary Intervention and Thrombus Aspiration
n=27 Participants
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.
Percutaneous Coronary Intervention: Standard of care
Thrombus Aspiration: Standard of care treatment with manual thrombectomy catheter
|
Percutaneous Coronary Intervention and Retriever Thrombectomy
n=27 Participants
Participants randomised to the stent-retriever thrombectomy arm of the RETRIEVE AMI trial will undergo stent-retriever thrombectomy with the SolitaireTM X Revascularisation Device.
Retriever Thrombectomy: 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.
Percutaneous Coronary Intervention: Standard of care
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 12 • n=27 Participants
|
63 years
STANDARD_DEVIATION 12 • n=27 Participants
|
63 years
STANDARD_DEVIATION 13 • n=27 Participants
|
64 years
STANDARD_DEVIATION 12 • n=81 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=27 Participants
|
5 Participants
n=27 Participants
|
4 Participants
n=27 Participants
|
12 Participants
n=81 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=27 Participants
|
22 Participants
n=27 Participants
|
23 Participants
n=27 Participants
|
69 Participants
n=81 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
27 participants
n=27 Participants
|
27 participants
n=27 Participants
|
27 participants
n=27 Participants
|
81 participants
n=81 Participants
|
PRIMARY outcome
Timeframe: During PCI prior to stent implantation (typically 30 min from start of procedure)Population: The OCT run for one patient was not analysable due to slow flow precluding good blood clearance for a reliable measurement.
Assessed with Optical Coherence Tomography \[OCT\]
Outcome measures
| Measure |
Standalone Percutaneous Coronary Intervention
n=27 Participants
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.
Percutaneous Coronary Intervention: Standard of care
|
Percutaneous Coronary Intervention and Thrombus Aspiration
n=26 Participants
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.
Percutaneous Coronary Intervention: Standard of care
Thrombus Aspiration: Standard of care treatment with manual thrombectomy catheter
|
Percutaneous Coronary Intervention and Retriever Thrombectomy
n=27 Participants
Participants randomised to the stent-retriever thrombectomy arm of the RETRIEVE AMI trial will undergo stent-retriever thrombectomy with the SolitaireTM X Revascularisation Device.
Retriever Thrombectomy: 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.
Percutaneous Coronary Intervention: Standard of care
|
|---|---|---|---|
|
Thrombus Volume (mm^3)
|
9.8 mm^3
Interval 4.5 to 18.1
|
4.8 mm^3
Interval 1.8 to 8.4
|
7.7 mm^3
Interval 2.3 to 18.6
|
PRIMARY outcome
Timeframe: During PCI prior to stent implantation (typically 30 min from start of procedure)Assessed with angiography and/or OCT
Outcome measures
| Measure |
Standalone Percutaneous Coronary Intervention
n=27 Participants
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.
Percutaneous Coronary Intervention: Standard of care
|
Percutaneous Coronary Intervention and Thrombus Aspiration
n=27 Participants
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.
Percutaneous Coronary Intervention: Standard of care
Thrombus Aspiration: Standard of care treatment with manual thrombectomy catheter
|
Percutaneous Coronary Intervention and Retriever Thrombectomy
n=27 Participants
Participants randomised to the stent-retriever thrombectomy arm of the RETRIEVE AMI trial will undergo stent-retriever thrombectomy with the SolitaireTM X Revascularisation Device.
Retriever Thrombectomy: 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.
Percutaneous Coronary Intervention: Standard of care
|
|---|---|---|---|
|
Device-related Target Vessel Complications
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During PCI prior to stent implantation (typically 30 min from start of procedure)Assessed with angiography and/or OCT
Outcome measures
| Measure |
Standalone Percutaneous Coronary Intervention
n=27 Participants
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.
Percutaneous Coronary Intervention: Standard of care
|
Percutaneous Coronary Intervention and Thrombus Aspiration
n=27 Participants
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.
Percutaneous Coronary Intervention: Standard of care
Thrombus Aspiration: Standard of care treatment with manual thrombectomy catheter
|
Percutaneous Coronary Intervention and Retriever Thrombectomy
n=27 Participants
Participants randomised to the stent-retriever thrombectomy arm of the RETRIEVE AMI trial will undergo stent-retriever thrombectomy with the SolitaireTM X Revascularisation Device.
Retriever Thrombectomy: 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.
Percutaneous Coronary Intervention: Standard of care
|
|---|---|---|---|
|
Device Deficiency
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after PCIOutcome measures
| Measure |
Standalone Percutaneous Coronary Intervention
n=27 Participants
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.
Percutaneous Coronary Intervention: Standard of care
|
Percutaneous Coronary Intervention and Thrombus Aspiration
n=27 Participants
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.
Percutaneous Coronary Intervention: Standard of care
Thrombus Aspiration: Standard of care treatment with manual thrombectomy catheter
|
Percutaneous Coronary Intervention and Retriever Thrombectomy
n=27 Participants
Participants randomised to the stent-retriever thrombectomy arm of the RETRIEVE AMI trial will undergo stent-retriever thrombectomy with the SolitaireTM X Revascularisation Device.
Retriever Thrombectomy: 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.
Percutaneous Coronary Intervention: Standard of care
|
|---|---|---|---|
|
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
|
2 Participants
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At 6 months after PCIPopulation: MACCE not available to all participants as two withdrew their consent for participation.
Outcome measures
| Measure |
Standalone Percutaneous Coronary Intervention
n=26 Participants
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.
Percutaneous Coronary Intervention: Standard of care
|
Percutaneous Coronary Intervention and Thrombus Aspiration
n=26 Participants
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.
Percutaneous Coronary Intervention: Standard of care
Thrombus Aspiration: Standard of care treatment with manual thrombectomy catheter
|
Percutaneous Coronary Intervention and Retriever Thrombectomy
n=27 Participants
Participants randomised to the stent-retriever thrombectomy arm of the RETRIEVE AMI trial will undergo stent-retriever thrombectomy with the SolitaireTM X Revascularisation Device.
Retriever Thrombectomy: 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.
Percutaneous Coronary Intervention: Standard of care
|
|---|---|---|---|
|
MACCE
|
5 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During PCI prior to stent implantation (typically 30 min from start of procedure)Population: The OCT run for one patient was not analysable due to slow flow precluding good blood clearance for a reliable measurement.
Assessed with OCT
Outcome measures
| Measure |
Standalone Percutaneous Coronary Intervention
n=27 Participants
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.
Percutaneous Coronary Intervention: Standard of care
|
Percutaneous Coronary Intervention and Thrombus Aspiration
n=26 Participants
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.
Percutaneous Coronary Intervention: Standard of care
Thrombus Aspiration: Standard of care treatment with manual thrombectomy catheter
|
Percutaneous Coronary Intervention and Retriever Thrombectomy
n=27 Participants
Participants randomised to the stent-retriever thrombectomy arm of the RETRIEVE AMI trial will undergo stent-retriever thrombectomy with the SolitaireTM X Revascularisation Device.
Retriever Thrombectomy: 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.
Percutaneous Coronary Intervention: Standard of care
|
|---|---|---|---|
|
Flow Volume (mm^3)
|
30.6 mm^3
Interval 19.7 to 65.0
|
35.9 mm^3
Interval 15.1 to 91.7
|
66.5 mm^3
Interval 41.8 to 108.6
|
SECONDARY outcome
Timeframe: Post-stent implantation during PCI (typically 50 min after procedure start)Population: One patient was crossed over to direct stent implantation due to radial spasm precluding stent retriever thrombectomy. The OCT runs for some patients were not analysable due to slow flow precluding good blood clearance for a reliable measurement.
Assessed with OCT
Outcome measures
| Measure |
Standalone Percutaneous Coronary Intervention
n=28 Participants
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.
Percutaneous Coronary Intervention: Standard of care
|
Percutaneous Coronary Intervention and Thrombus Aspiration
n=26 Participants
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.
Percutaneous Coronary Intervention: Standard of care
Thrombus Aspiration: Standard of care treatment with manual thrombectomy catheter
|
Percutaneous Coronary Intervention and Retriever Thrombectomy
n=24 Participants
Participants randomised to the stent-retriever thrombectomy arm of the RETRIEVE AMI trial will undergo stent-retriever thrombectomy with the SolitaireTM X Revascularisation Device.
Retriever Thrombectomy: 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.
Percutaneous Coronary Intervention: Standard of care
|
|---|---|---|---|
|
Thromboatheroma Volume (mm^3)
|
3.4 mm^3
Interval 1.1 to 6.3
|
1.8 mm^3
Interval 0.6 to 4.7
|
0.5 mm^3
Interval 0.0 to 2.8
|
SECONDARY outcome
Timeframe: Post-stent implantation during PCI (typically 50 min after procedure start)Population: One patient was crossed over to direct stent implantation due to radial spasm precluding stent retriever thrombectomy. The OCT runs for some patients were not analysable due to slow flow precluding good blood clearance for a reliable measurement.
Assessed with OCT
Outcome measures
| Measure |
Standalone Percutaneous Coronary Intervention
n=28 Participants
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.
Percutaneous Coronary Intervention: Standard of care
|
Percutaneous Coronary Intervention and Thrombus Aspiration
n=26 Participants
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.
Percutaneous Coronary Intervention: Standard of care
Thrombus Aspiration: Standard of care treatment with manual thrombectomy catheter
|
Percutaneous Coronary Intervention and Retriever Thrombectomy
n=24 Participants
Participants randomised to the stent-retriever thrombectomy arm of the RETRIEVE AMI trial will undergo stent-retriever thrombectomy with the SolitaireTM X Revascularisation Device.
Retriever Thrombectomy: 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.
Percutaneous Coronary Intervention: Standard of care
|
|---|---|---|---|
|
Flow Volume (mm^3)
|
5.9 mm^3
Interval 4.7 to 7.1
|
6.3 mm^3
Interval 5.0 to 7.4
|
7.2 mm^3
Interval 5.4 to 8.7
|
SECONDARY outcome
Timeframe: Post-stent implantation during PCI (typically 50 min after procedure start)Population: One patient was crossed over to direct stent implantation due to radial spasm precluding stent retriever thrombectomy. The OCT runs for some patients were not analysable due to slow flow precluding good blood clearance for a reliable measurement.
Assessed with OCT according to established international consensus criteria.
Outcome measures
| Measure |
Standalone Percutaneous Coronary Intervention
n=28 Participants
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.
Percutaneous Coronary Intervention: Standard of care
|
Percutaneous Coronary Intervention and Thrombus Aspiration
n=26 Participants
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.
Percutaneous Coronary Intervention: Standard of care
Thrombus Aspiration: Standard of care treatment with manual thrombectomy catheter
|
Percutaneous Coronary Intervention and Retriever Thrombectomy
n=24 Participants
Participants randomised to the stent-retriever thrombectomy arm of the RETRIEVE AMI trial will undergo stent-retriever thrombectomy with the SolitaireTM X Revascularisation Device.
Retriever Thrombectomy: 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.
Percutaneous Coronary Intervention: Standard of care
|
|---|---|---|---|
|
Number of Participants With Stent Underexpansion & Malapposition
|
5 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Post-stent implantation during PCI (typically 60 min after procedure start)Population: TIMI less than 3
Assessed with angiography according to the TIMI Flow criteria
Outcome measures
| Measure |
Standalone Percutaneous Coronary Intervention
n=27 Participants
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.
Percutaneous Coronary Intervention: Standard of care
|
Percutaneous Coronary Intervention and Thrombus Aspiration
n=27 Participants
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.
Percutaneous Coronary Intervention: Standard of care
Thrombus Aspiration: Standard of care treatment with manual thrombectomy catheter
|
Percutaneous Coronary Intervention and Retriever Thrombectomy
n=27 Participants
Participants randomised to the stent-retriever thrombectomy arm of the RETRIEVE AMI trial will undergo stent-retriever thrombectomy with the SolitaireTM X Revascularisation Device.
Retriever Thrombectomy: 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.
Percutaneous Coronary Intervention: Standard of care
|
|---|---|---|---|
|
Thrombolysis in Myocardial Infarction (TIMI) Flow
|
10 Participants
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standalone Percutaneous Coronary Intervention
n=27 Participants
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.
Percutaneous Coronary Intervention: Standard of care
|
Percutaneous Coronary Intervention and Thrombus Aspiration
n=27 Participants
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.
Percutaneous Coronary Intervention: Standard of care
Thrombus Aspiration: Standard of care treatment with manual thrombectomy catheter
|
Percutaneous Coronary Intervention and Retriever Thrombectomy
n=27 Participants
Participants randomised to the stent-retriever thrombectomy arm of the RETRIEVE AMI trial will undergo stent-retriever thrombectomy with the SolitaireTM X Revascularisation Device.
Retriever Thrombectomy: 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.
Percutaneous Coronary Intervention: Standard of care
|
|---|---|---|---|
|
Number of Participants With Myocardial Blush Grade (MBG) < 3
|
14 Participants
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Post-stent implantation during PCI (typically 60 min after procedure start)Population: The measurement was secondary and to the discretion of the treating physician.
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.
Outcome measures
| Measure |
Standalone Percutaneous Coronary Intervention
n=23 Participants
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.
Percutaneous Coronary Intervention: Standard of care
|
Percutaneous Coronary Intervention and Thrombus Aspiration
n=22 Participants
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.
Percutaneous Coronary Intervention: Standard of care
Thrombus Aspiration: Standard of care treatment with manual thrombectomy catheter
|
Percutaneous Coronary Intervention and Retriever Thrombectomy
n=19 Participants
Participants randomised to the stent-retriever thrombectomy arm of the RETRIEVE AMI trial will undergo stent-retriever thrombectomy with the SolitaireTM X Revascularisation Device.
Retriever Thrombectomy: 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.
Percutaneous Coronary Intervention: Standard of care
|
|---|---|---|---|
|
Angiograpicy Derived Index of Microcirculatory Resistance
|
50.0 units
Interval 35.8 to 74.0
|
41 units
Interval 30.9 to 47.9
|
40.6 units
Interval 35.7 to 50.1
|
Adverse Events
Standalone Percutaneous Coronary Intervention
Serious events: 5 serious events
Other events: 0 other events
Deaths: 2 deaths
Percutaneous Coronary Intervention and Thrombus Aspiration
Serious events: 4 serious events
Other events: 2 other events
Deaths: 1 deaths
Percutaneous Coronary Intervention and Retriever Thrombectomy
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standalone Percutaneous Coronary Intervention
n=27 participants at risk
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.
Percutaneous Coronary Intervention: Standard of care
|
Percutaneous Coronary Intervention and Thrombus Aspiration
n=27 participants at risk
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.
Percutaneous Coronary Intervention: Standard of care
Thrombus Aspiration: Standard of care treatment with manual thrombectomy catheter
|
Percutaneous Coronary Intervention and Retriever Thrombectomy
n=27 participants at risk
Participants randomised to the stent-retriever thrombectomy arm of the RETRIEVE AMI trial will undergo stent-retriever thrombectomy with the SolitaireTM X Revascularisation Device.
Retriever Thrombectomy: 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.
Percutaneous Coronary Intervention: Standard of care
|
|---|---|---|---|
|
Cardiac disorders
Arrhtymia Related Unplanned Admission
|
3.7%
1/27 • Number of events 1 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
11.1%
3/27 • Number of events 3 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
3.7%
1/27 • Number of events 1 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
|
Cardiac disorders
Death (Prespecified clinical endpoint)
|
7.4%
2/27 • Number of events 2 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
3.7%
1/27 • Number of events 1 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
0.00%
0/27 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
|
General disorders
Chest discomfort
|
3.7%
1/27 • Number of events 1 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
0.00%
0/27 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
0.00%
0/27 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
|
Gastrointestinal disorders
Major GI Bleeding
|
3.7%
1/27 • Number of events 1 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
0.00%
0/27 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
0.00%
0/27 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
Other adverse events
| Measure |
Standalone Percutaneous Coronary Intervention
n=27 participants at risk
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.
Percutaneous Coronary Intervention: Standard of care
|
Percutaneous Coronary Intervention and Thrombus Aspiration
n=27 participants at risk
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.
Percutaneous Coronary Intervention: Standard of care
Thrombus Aspiration: Standard of care treatment with manual thrombectomy catheter
|
Percutaneous Coronary Intervention and Retriever Thrombectomy
n=27 participants at risk
Participants randomised to the stent-retriever thrombectomy arm of the RETRIEVE AMI trial will undergo stent-retriever thrombectomy with the SolitaireTM X Revascularisation Device.
Retriever Thrombectomy: 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.
Percutaneous Coronary Intervention: Standard of care
|
|---|---|---|---|
|
Cardiac disorders
Symptomatic Hypotension
|
0.00%
0/27 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
0.00%
0/27 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
7.4%
2/27 • Number of events 2 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
|
Cardiac disorders
Arrhtymia Related Unplanned Admission
|
0.00%
0/27 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
3.7%
1/27 • Number of events 1 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
0.00%
0/27 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
|
Cardiac disorders
Chest discomfort
|
0.00%
0/27 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
3.7%
1/27 • Number of events 1 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
7.4%
2/27 • Number of events 2 • Adverse events were captured at 6 months.
The events recorded in the MACCE section are not adverse events, but rather protocol prespecified clinical endpoints.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place