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

Ceric Sàrl

Status

Not yet enrolling

Conditions

Anterior Myocardial Infarction

Treatments

Procedure: THROMBOASPIRATION WITH INDIGO SYSTEM

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT06887413

TACTIC

Details and patient eligibility

About

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

Full 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

Enrollment

140 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

Age >18 and <75 years old
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
Culprit lesion proximal or mid LAD at coronary angiography
TIMI thrombus grading > 3 or TIMI flow 0 after guidewire crossing the lesion.
Patient presents to the hospital between 1 - 6 hours of ischemic pain onset
Patient indicated for primary percutaneous coronary intervention (PPCI)

EXCLUSION CRITERIA

Unable to give Informed consent.
Life expectancy < 1 year.
Contraindication to PCI
STEMI due to stent thrombosis
Spontaneous coronary aretery dissection
Patient undergone any kind of maneuvers to restore flow before randomization
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
New onset of stroke symptoms and NIHSS >2, prior to index procedure
Known intolerance to aspirin, clopidogrel, ticagrelor, heparin, contrast media.
Active severe bleeding
Severe hepatic/kidney impairment
Administration of fibrinolytic therapy within 24 hours prior to enrolment
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
Inferior STEMI or suspected right ventricular failure
Severe valvulopathy
Acute cardiac mechanical complication: LV-free wall rupture OR interventricular septum rupture OR acute mitral regurgitation

Medical Conditions & History:

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

Cardiovascular history

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