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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOxford University Hospitals NHS Trust

About this trial

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

Qualifiers

Primary PCI patient with ST elevation myocardial infarction

TIMI 0/1 flow at presentation

Angiographic thrombus score ≥ 4

Vessel diameter at site of occlusion ≥ 3.0mm (determined by coronary angiography)

Disqualifiers

Female participant who is pregnant or lactating

Unconscious at presentation

Late STEMI presentation (symptoms onset to wire time > 12 h)

Clinically/haemodynamically unstable patients

Trial design

Treatments tested in this trial

  • Sustained thrombectomy
  • Percutaneous Coronary Intervention

Treatment groups

60 Participants
are divided into 2 treatment groups