Coronary Thrombus Aspiration with Cath Rx in anTerior myocardIal infarCtion: a randomized control trial (TACTIC)

Research summary

TACTIC is a prospective, investigator-initiated, multicenter, randomized, controlled, open-label, PMCF clinical study. The medical device used in the study is the Indigo™ CAT RX Aspiration Catheters and Indigo Separator (manufacturer Penumbra, Alameda, California 94502 USA) consists of several components of which, the Indigo CAT RX Aspiration Catheter and the INDIGO Separator are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The device system received the CE mark in November 2021. The primary objective of this study is to demonstrate that primary thrombus aspiration with CAT RX has the following effects when compared to the current standard of care of patients presenting with Anterior ST-elevation myocardial infarction (STEMI) to demonstrate the safety and efficacy of primary thrombus aspiration with CAT RX versus current standard of care in reducing infarct size and heart failure-related clinical events in patients presenting with anterior STEMI. Patients will be selected based on the inclusion and exclusion criteria set out in the protocol. Recruitment will last 12 months. It is planned to enrol 140 patients in up to 23 hospitals in 3 EU countries. Patient participation will last for 1 year. Patient assessments are scheduled as baseline, procedure, 3-5 days post-procedure, discharge, 30-day, and 12-month physical visits. An additional 2 years patient’s follow-up might be performed (clinical or phone). In that case the participation for each patient would be 3 years. Aspiration with Indigo™ CAT Rx Aspiration Catheters and all examinations will be performed according to Instructions for Use and according to current clinical practice at participating hospitals. The treatment does not result in any direct benefit for the patient. Enrolled patients must receive the standard of care provided by the participating center during the study and after the end of their participation.

Principal Investigator

Dr Giovanni Luigi De Maria

Contact us

Email: oxfordheartresearch@ouh.nhs.uk

IRAS number

364610