NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07687576

RecruitingPhase 2, Phase 3

Sponsor: Oxford University Hospitals NHS Trust

Conditions: STEMI - ST Elevation Myocardial Infarction

Interventions: Sustained thrombectomy, Percutaneous Coronary Intervention

Countries: United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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)

Locations (1)

Oxford, Oxfordshire, United Kingdom