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The CAPTURE AMI trial is an investigator-initiated, single-centre, two-arm, randomised controlled trial. Patients aged ≥ 18 years who present with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI) will be enrolled after angiographic evidence of a high thrombus burden (TIMI thrombus grade ≥ 4) and meeting the inclusion criteria laid out in section 9.2 will be 1:1 randomised to receive either standalone PCI (Arm 1) or adjunct sustained mechanical thrombectomy + PCI (Arm 2).
The CAPTURE AMI study will enrol specifically patients with:
A. Evidence of high thrombus burden on coronary angiography (TIMI thrombus grade ≥ 4) B. Culprit in an artery with a diameter of 3.0 mm or more. The trial is designed to evaluate the efficacy of sustained mechanical thrombectomy versus standalone PCI in patients with a large thrombus burden assessed angiographically, with a pre-stent thrombus burden (%) as the primary imaging endpoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standalone PCI | Active Comparator | Standalone OCT guided PCI |
|
| PCI & Sustained thrombectomy | Experimental | OCT guided PCI & Sustained Thrombectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sustained thrombectomy | Device | Sustained thrombectomy with the Indigo® System CAT™ RX aspiration catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pre stent Thrombus Burden | Pre stent Thrombus Burden (thrombus volume/lumen volume) evaluated by Optical Coherence Tomography | Pre stent implantation (Periprocedural) |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcomes | Rate of major adverse cardiac and cerebrovascular events (MACCE) | In hospital (Pre-discharge), 30 days & 6 months |
| Efficacy of thrombus burden reduction | Thrombus volume (mm3) by Optical Coherence Tomography |
Inclusion Criteria:
Primary PCI patient with ST elevation myocardial infarction
Angiographic criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovanni Luigi De Maria, MD | Contact | +44 18655 528364 | GiovanniLuigi.DeMaria@ouh.nhs.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford Heart Centre - John Radcliffe Hospital | Recruiting | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40555011 | Background | Kotronias RA, Walsh JL, Andreaggi S, Portolan L, Maino A, Marin F, Chai J, Sobirov I, Sheikh M, Cahill TJ, Lucking AJ, Costello M, Fraile Moreno E, Haridas V, Shaji A, Garcia-Garcia HM, Channon KM, Banning AP, Langrish JP, De Maria GL; OxAMI and RETRIEVE AMI Investigators. Stent-Retriever Thrombectomy in STEMI With Large Thrombus Burden: The RETRIEVE AMI Randomized Trial. JACC Adv. 2025 Jul;4(7):101893. doi: 10.1016/j.jacadv.2025.101893. Epub 2025 Jun 23. | |
| 38565957 |
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| Percutaneous Coronary Intervention | Procedure | Optical Coherence Tomography guided Percutaneous Coronary Intervention |
|
| Pre stent implantation (Periprocedural) |
| Efficacy of thrombus burden reduction | Thrombus area, flow area (mm2) by Optical Coherence Tomography | Pre stent Implantation (Periprocedural) |
| Efficacy of thromboatheroma reduction | Thromboatheroma volume (mm3), flow volume (mm3) by Optical Coherence Tomography | Post stent implantation (Periprocedural) |
| Efficacy of target vessel reperfusion | Coronary Flow Reserve (CFR) and Index of Microcirculatory Resistance (IMR) assessment in target vessel | Post stent Implantation (Periprocedural) |
| Efficacy of stent implantation | Stent expansion & apposition by Optical Coherence Tomography | Post stent implantation (Periprocedural) |
| Background |
| Walsh JL, Kotronias RA, Banning AP, De Maria GL. Interventional thrombus modification in STEMI. Nat Rev Cardiol. 2024 Jul;21(7):435-436. doi: 10.1038/s41569-024-01020-2. No abstract available. |
| 36894360 | Background | Kotronias RA, Marin F, Emfietzoglou M, Langrish JP, Lucking AJ, Channon KM, Banning AP, De Maria GL. Rationale and Design of a Randomized Controlled Pilot Trial to Assess Stent Retriever Thrombectomy for Thrombus Burden Reduction in Patients with Acute Myocardial Infarction: The RETRIEVE-AMI Study. Cardiovasc Revasc Med. 2023 Jul;52:75-85. doi: 10.1016/j.carrev.2023.02.012. Epub 2023 Mar 6. |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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