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

Not Applicable

Not yet recruiting

• Conditions: Anterior Myocardial Infarction

• Registration Number: NCT06887413
• Lead Sponsor: Ceric Sàrl

Brief 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

Study Timeline

• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-19
• Study First Posted: 2025-03-20
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-15
• Study Start: 2025-09-01
• Primary Completion: 2026-06-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Microvascular obstruction	Within 3-5 days post procedure	Incidence of Microvascular obstruction (MVO) assessed by Cardiac Magnetic Resonance

Secondary Outcome Measures

Name	Time	Method
Secondary CMR endpoint:	Within 3-5 days post procedure	Left Ventricular Mass in % 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:	At the end of the procedure	Incidence of TIMI 3 flow at the end of primary PCI Post PCI non-hyperemic angio-derived IMR measurements. PCI
Safety endpoint	At 1 month post procedure	Incidence of device-related SAE(s) and Stroke

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milano, Milani, Italy