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

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

Eligibility

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

Conditions2

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