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

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

Study Overview

• Status: Recruiting
• Conditions: Anterior Myocardial Infarction
• Intervention / Treatment: Procedure: THROMBOASPIRATION WITH INDIGO SYSTEM

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 Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Phani Krishna KONDAMUDI; Phone Number: +33 (0)1 60 11 17 91; Email: pkondamudi@cerc-europe.org

Study Locations

• Italy
  • Milani
    • Milan, Milani, Italy, 20132
      • Recruiting
      • IRCCS Ospedale San Raffaele
      • Contact: Alaide Chieffo; Phone Number: +39 02.26431; Email: cecalaide@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

INCLUSION CRITERIA

1. Age >18 and <75 years old
2. Acute anterior STEMI with ≥2 mm in two (2) or more contiguous anterior leads or ≥4 mm total ST-segment deviation sum in the anterior leads V1-V4 AND anterior wall motion abnormality noted on a diagnostic quality left ventriculogram or echocardiogram
3. Culprit lesion proximal or mid LAD at coronary angiography
4. TIMI thrombus grading > 3 or TIMI flow 0 after guidewire crossing the lesion.
5. Patient presents to the hospital between 1 - 6 hours of ischemic pain onset
6. Patient indicated for primary percutaneous coronary intervention (PPCI)

EXCLUSION CRITERIA

1. Unable to give Informed consent.
2. Life expectancy < 1 year.
3. Contraindication to PCI
4. STEMI due to stent thrombosis
5. Spontaneous coronary aretery dissection
6. Patient undergone any kind of maneuvers to restore flow before randomization
7. Unwitnessed cardiac arrest OR ≥30 minutes of cardiopulmonary resuscitation (CPR) prior to enrolment OR any cardiac arrest with impairment in mental status, cognition or any global or focal neurological deficit
8. New onset of stroke symptoms and NIHSS >2, prior to index procedure
9. Known intolerance to aspirin, clopidogrel, ticagrelor, heparin, contrast media.
10. Active severe bleeding
11. Severe hepatic/kidney impairment
12. Administration of fibrinolytic therapy within 24 hours prior to enrolment
13. Cardiogenic shock defined as systemic hypotension (systolic BP <90 mmHg or the need for inotropes/pressors to maintain a systolic BP >90 mmHg), plus one (1) of the following: any requirement for pressors / inotropes prior to arrival at the catheterization laboratory, clinical evidence of end-organ hypoperfusion, or use of IABP or any other mechanical circulatory support device
14. Inferior STEMI or suspected right ventricular failure
15. Severe valvulopathy
16. Acute cardiac mechanical complication: LV-free wall rupture OR interventricular septum rupture OR acute mitral regurgitation

Medical Conditions & History:

1. Suspected or known pregnancy
2. Suspected systemic active infection
3. History or known hepatic insufficiency prior to catheterization
4. Undergoing a renal replacement therapy
5. Chronic obstructive pulmonary disease (COPD) with home oxygen therapy or on chronic steroid therapy
6. Contraindication to perform MRI or use gadolinium [creatinine clearance (CrCl) <30 mL/min, non-compatible implant, claustrophobia]

Cardiovascular history

1. Known or evidence of prior MI, including pathologic Q-waves in non-anterior leads
2. Prior coronary artery bypass graft surgery (CABG) or LAD PCI
3. History of heart failure (documented history of EF <40% or documented hospitalization for HF within 1 year prior to screening
4. Prior aortic valve surgery or TAVR
5. Left bundle branch block (new or old)
6. History of stroke/TIA within 3 months prior to screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Subjects randomized to the control arm will be treated with standard PPCI
Experimental: - Treatment arm: Subjects randomized to the treatment arm will be treated with the CAT RX; Treatment arm: Subjects randomized to the treatment arm will be treated with the CAT RX	Procedure: THROMBOASPIRATION WITH INDIGO SYSTEM; Subjects randomized to the treatment arm will be treated with the CAT RX as previously described.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microvascular obstruction	Incidence of Microvascular obstruction (MVO) assessed by Cardiac Magnetic Resonance	Within 3-5 days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary CMR endpoint:	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)	Within 3-5 days post procedure
Secondary exploratory clinical and angiographic endpoint:	Incidence of TIMI 3 flow at the end of primary PCI Post PCI non-hyperemic angio-derived IMR measurements. PCI	At the end of the procedure
Safety endpoint	Incidence of 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	At 1 year Follow Up
Safety endpoint	Incidence of device-related SAE(s) and Stroke	At 1 month post procedure

Collaborators and Investigators

• Sponsor: Ceric Sàrl
• Collaborators: European Cardiovascular Research Center
• Investigators: Principal Investigator: Alaide Chieffo, San Raffaele Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: STEMI; thromboaspiration; anterior myocardial infarction; INDIGO CAT RX; indigo system; HEART ATTACK
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction; Myocardial Infarction; Anterior Wall Myocardial Infarction
• Other Study ID Numbers: TACTIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No