STEMI - ST Elevation Myocardial Infarction
Conditions
Keywords
Thrombus, Thrombectomy, Optical Coherence Tomography, Microvascular Injury
Brief summary
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
DEVICESustained thrombectomy
Sustained thrombectomy with the Indigo® System CAT™ RX aspiration catheter
PROCEDUREPercutaneous Coronary Intervention
Optical Coherence Tomography guided Percutaneous Coronary Intervention
Sponsors
Oxford University Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre stent Thrombus Burden | Pre stent implantation (Periprocedural) | Pre stent Thrombus Burden (thrombus volume/lumen volume) evaluated by Optical Coherence Tomography |
Countries
United Kingdom
Contacts
CONTACTGiovanni Luigi De Maria, MD
Outcome results
None listed