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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• IRCCS Ospedale San Raffaele
  Milan, Milani, Italy Recruiting

Study contacts

• Principal investigator: Alaide Chieffo — San Raffaele Hospital
• Study coordinator: Phani Krishna KONDAMUDI
• Email: pkondamudi@cerc-europe.org
• Phone: +33 (0)1 60 11 17 91

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.