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 (CAPTURE AMI)

July 1, 2026 updated by: Giovanni Luigi De Maria, Oxford University Hospitals NHS Trust

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Oxford Heart Centre - John Radcliffe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standalone PCI
Standalone OCT guided PCI
Procedure: Percutaneous Coronary Intervention
Optical Coherence Tomography guided Percutaneous Coronary Intervention
Experimental: PCI & Sustained thrombectomy
OCT guided PCI & Sustained Thrombectomy
Procedure: Percutaneous Coronary Intervention
Optical Coherence Tomography guided Percutaneous Coronary Intervention
Device: Sustained thrombectomy
Sustained thrombectomy with the Indigo® System CAT™ RX aspiration catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre stent Thrombus Burden
Time Frame: Pre stent implantation (Periprocedural)
Pre stent Thrombus Burden (thrombus volume/lumen volume) evaluated by Optical Coherence Tomography
Pre stent implantation (Periprocedural)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcomes
Time Frame: In hospital (Pre-discharge), 30 days & 6 months
Rate of major adverse cardiac and cerebrovascular events (MACCE)
In hospital (Pre-discharge), 30 days & 6 months
Efficacy of thrombus burden reduction
Time Frame: Pre stent implantation (Periprocedural)
Thrombus volume (mm3) by Optical Coherence Tomography
Pre stent implantation (Periprocedural)
Efficacy of thrombus burden reduction
Time Frame: Pre stent Implantation (Periprocedural)
Thrombus area, flow area (mm2) by Optical Coherence Tomography
Pre stent Implantation (Periprocedural)
Efficacy of thromboatheroma reduction
Time Frame: Post stent implantation (Periprocedural)
Thromboatheroma volume (mm3), flow volume (mm3) by Optical Coherence Tomography
Post stent implantation (Periprocedural)
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
Post stent Implantation (Periprocedural)
Efficacy of stent implantation
Time Frame: Post stent implantation (Periprocedural)
Stent expansion & apposition by Optical Coherence Tomography
Post stent implantation (Periprocedural)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford University Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

June 25, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19672

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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