Coronary thrombus removal with INDIGO CAT RX for anterior heart attacks.

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

This trial will test whether using the INDIGO CAT RX device to suction clot during primary PCI reduces microvascular damage and heart muscle scarring in people with an anterior STEMI.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Ceric Sàrl (industry)
• Locations: 1 site (Milan, Milani)
• Trial ID: NCT06887413 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized 1:1, open-label multicenter trial enrolling 140 patients with proximal or mid LAD occlusions causing anterior STEMI. Participants are randomized to sustained thrombectomy with the INDIGO CAT RX device versus standard primary PCI without thrombectomy. All participants undergo a cardiac MRI with gadolinium 3–5 days after PCI to measure microvascular obstruction and infarct size, with clinical follow-up at 30 days and 12 months. The primary endpoint is microvascular obstruction measured by CMR mass at 3–5 days, with multiple CMR volumetric and clinical/angiographic secondary endpoints.

Who should consider this trial

Good fit: Adults aged 18–74 who present within 1–6 hours of ischemic pain with acute anterior STEMI due to a proximal or mid LAD occlusion and high thrombus burden (TIMI thrombus >3 or TIMI 0 after wiring) and who are candidates for primary PCI.

Not a fit: Patients with non-anterior MI, STEMI from stent thrombosis, spontaneous coronary artery dissection, presentation beyond 6 hours, low thrombus burden, contraindications to PCI or cardiac MRI, or life expectancy under one year are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, using the device could lead to smaller infarcts and less microvascular injury, preserving heart function and lowering risk of future heart failure.

How similar studies have performed: Previous routine manual aspiration trials in STEMI showed mixed results and no clear mortality benefit, so the INDIGO sustained thrombectomy approach is relatively novel and not yet proven in large outcome trials.

Eligibility criteria

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

Where this trial is running

Milan, Milani

• IRCCS Ospedale San Raffaele — Milan, Milani, Italy (RECRUITING)

Study contacts

• Principal investigator: Alaide Chieffo — San Raffaele Hospital
• Study coordinator: Phani Krishna KONDAMUDI

Conditions: Anterior Myocardial Infarction, STEMI, thromboaspiration, anterior myocardial infarction, INDIGO CAT RX, indigo system, HEART ATTACK