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Recruiting NCT07687576

Comparative Evaluation of Sustained meChanical AsPiration Thrombectomy and no Thrombus Modification for Pre-stent Thrombus bUrden Reduction in Patients With Acute Myocardial Infarction Study: the CAPTURE AMI Study

Conditions: STEMI - ST Elevation Myocardial Infarction

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 60
Sponsor: Oxford University Hospitals NHS Trust

Location: Oxford Heart Centre - John Radcliffe Hospital Oxford Oxfordshire

Summary

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.

Eligibility Criteria

Inclusion Criteria: * Primary PCI patient with ST elevation myocardial infarction * Angiographic criteria: * TIMI 0/1 flow at presentation * Angiographic thrombus score ≥ 4 * Vessel diameter at site of occlusion ≥ 3.0mm (determined by coronary angiography) Exclusion Criteria: * Female participant who is pregnant or lactating * Unconscious at presentation * Late STEMI presentation (symptoms onset to wire time \> 12 h) * Clinically/haemodynamically unstable patients * Known diagnosis of severe renal disease (CKD stage 4-5) * Suspected spontaneous coronary artery dissection * Previous CABG * Previous history on STEMI in the same culprit territory * Known moderate-severe anaemia (Hb \< 9)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07687576). StuddyBuddy aggregates publicly available trial information.