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NCT Number: 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

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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Key information

Conditions

STEMI - ST Elevation Myocardial Infarction Cardiovascular Diseases Embolism and Thrombosis Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Oxford Heart Centre - John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sustained thrombectomy

Device

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

Percutaneous coronary intervention

Procedure

Optical Coherence Tomography guided Percutaneous Coronary Intervention

Primary outcomes

  1. Pre stent Thrombus Burden

    Time frame: Pre stent implantation (Periprocedural)

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

Other outcomes

  1. Clinical Outcomes

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

    Rate of major adverse cardiac and cerebrovascular events (MACCE)

  2. Efficacy of thrombus burden reduction

    Time frame: Pre stent implantation (Periprocedural)

    Thrombus volume (mm3) by Optical Coherence Tomography

  3. Efficacy of thrombus burden reduction

    Time frame: Pre stent Implantation (Periprocedural)

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

  4. Efficacy of thromboatheroma reduction

    Time frame: Post stent implantation (Periprocedural)

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

  5. Efficacy of target vessel reperfusion

    Time frame: Post stent Implantation (Periprocedural)

    Coronary Flow Reserve (CFR) and Index of Microcirculatory Resistance (IMR) assessment in target vessel

  6. Efficacy of stent implantation

    Time frame: Post stent implantation (Periprocedural)

    Stent expansion & apposition by Optical Coherence Tomography

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Luigi De Maria, MD

CONTACT

[email protected]

+44 18655 528364

Sponsors and collaborators

Lead sponsor

Oxford University Hospitals NHS Trust

Other

Registry information

Acronym: CAPTURE AMI

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 7, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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