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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

ConditionSTEMI - ST Elevation Myocardial Infarction
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Sustained thrombectomy

    Device

    Sustained thrombectomy with the Indigo® System CAT™ RX aspiration catheter

  • Percutaneous Coronary Intervention

    Procedure/Surgery

    Optical Coherence Tomography guided Percutaneous Coronary Intervention

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Standalone PCIActive comparator 1 intervention
Group B: PCI & Sustained thrombectomyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pre stent Thrombus Burden

Pre stent Thrombus Burden (thrombus volume/lumen volume) evaluated by Optical Coherence Tomography

Time frame
Pre stent implantation (Periprocedural)

Secondary outcomes

Other outcomes

1

Clinical Outcomes

Rate of major adverse cardiac and cerebrovascular events (MACCE)

Time frame
In hospital (Pre-discharge), 30 days & 6 months
2

Efficacy of thrombus burden reduction

Thrombus volume (mm3) by Optical Coherence Tomography

Time frame
Pre stent implantation (Periprocedural)
3

Efficacy of thrombus burden reduction

Thrombus area, flow area (mm2) by Optical Coherence Tomography

Time frame
Pre stent Implantation (Periprocedural)
4

Efficacy of thromboatheroma reduction

Thromboatheroma volume (mm3), flow volume (mm3) by Optical Coherence Tomography

Time frame
Post stent implantation (Periprocedural)

Sponsors and contacts

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Oxford University Hospitals NHS Trust

Lead sponsor

Source ClinicalTrials.gov
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