NCT06887413

TACTIC Coronary Thrombus Aspiration With Cath Rx In Anterior Myocardial Infarction: A Randomized Control Trial.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Ceric Sàrl · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the impact of sustained thrombectomy with INDIGO ASPIRATION SYSTEM using CAT RX versus no thrombectomy during primary percutaneous coronary intervention (PPCI) on microvascular obstruction and infarct size, as measured by cardiovascular magnetic resonance (CMR) between 3 and 5 days post PPCI, in patients with anterior STEMI

Detailed description

Prospective, randomized 1:1, controlled, open label, multicentred, investigator initiated clinical investigation in 14 European sites. 140 patients will be enrolled in the study after coronary angiography confirming prox or mid LAD occlusion. Patients will be randomised in one of the following arms: Treatment arm: Subjects randomized to the treatment arm will be treated with the CAT RX as previously described. Control arm: Subjects randomized to the control arm will be treated with standard PPCI . Participants will undergo a cardiac MRI, including gadolinium contrast imaging, within 3-5 days following the index procedure. If clinical contraindications prevent the MRI from being performed within this timeframe, it should be conducted as soon as the participant is clinically stable. After the discharge, In-person or phone follow-ups will take place at 30 days, and 12 months post-PCI. Primary endpoint will be measured at 3-5 days post procedure where a microvascular obstruction will be assed by CMR mass. Secondary endpoints will be assessed: Secondary CMR endpoint - measured at 3-5 days post PPCI:Infarct size, as a percent of LV mass * Left ventricular end-systolic volume (LVESV) * Left ventricular end-diastolic volume (LVEDV) * Left ventricular end-systolic volume index * Left ventricular end-diastolic volume index * Ejection fraction (EF) Secondary exploratory clinical and angiographic endpoint: Measured at the end of the procedure: * TIMI 3 flow at the end of primary PCI * Post PCI non-hyperemic angio-derived IMR measurements. PCI Measured at 1 year post procedure: \- MACE at 1-year follow-up (a composite end point of all-cause death, myocardial infarction, pMCS implant, target lesion revascularization, stent thrombosis, ICD implantation or HF hospitalizations) and each individual component. Safety endpoint: Measured at 1 month post procedure: \- Device-related SAE(s) and Stroke

Conditions

• Anterior Myocardial Infarction

Interventions

Type	Name	Description
PROCEDURE	THROMBOASPIRATION WITH INDIGO SYSTEM	Subjects randomized to the treatment arm will be treated with the CAT RX as previously described.

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-06-01
• Completion: 2027-07-01
• First posted: 2025-03-20
• Last updated: 2025-11-25

Locations

1 site across 1 country: Italy