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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

Phase II / Phase III Interventional STEMI - ST Elevation Myocardial Infarction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sustained thrombectomy, Percutaneous Coronary Intervention.
Who it may be relevant to
Registry conditions: STEMI - ST Elevation Myocardial Infarction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Sustained thrombectomy
    Sustained thrombectomy with the Indigo® System CAT™ RX aspiration catheter
  • Procedure Percutaneous Coronary Intervention
    Optical Coherence Tomography guided Percutaneous Coronary Intervention

Primary outcome measures

  • Pre stent Thrombus Burden [Time frame: Pre stent implantation (Periprocedural)]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • Oxford Heart Centre - John Radcliffe Hospital — Oxford

Publications

  • Kotronias RA, Walsh JL, Andreaggi S, Portolan L, Maino A, Marin F, Chai J, Sobirov I, Sheikh M, Cahill TJ, Lucking AJ, Costello M, Fraile Moreno E, Haridas V, Shaji A, Garcia-Garcia HM, Channon KM, Banning AP, Langrish JP, De Maria GL; OxAMI and RETRIEVE AMI Investigators. Stent-Retriever Thrombectomy in STEMI With Large Thrombus Burden: The RETRIEVE AMI Randomized Trial. JACC Adv. 2025 Jul;4(7):1 PMID 40555011
  • Walsh JL, Kotronias RA, Banning AP, De Maria GL. Interventional thrombus modification in STEMI. Nat Rev Cardiol. 2024 Jul;21(7):435-436. doi: 10.1038/s41569-024-01020-2. No abstract available. PMID 38565957
  • Kotronias RA, Marin F, Emfietzoglou M, Langrish JP, Lucking AJ, Channon KM, Banning AP, De Maria GL. Rationale and Design of a Randomized Controlled Pilot Trial to Assess Stent Retriever Thrombectomy for Thrombus Burden Reduction in Patients with Acute Myocardial Infarction: The RETRIEVE-AMI Study. Cardiovasc Revasc Med. 2023 Jul;52:75-85. doi: 10.1016/j.carrev.2023.02.012. Epub 2023 Mar 6. PMID 36894360

Identifiers

NCT: NCT07687576 · 19672

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗