New Clot-Sucking device could limit heart attack damage
NCT ID NCT06887413
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether using a special catheter to remove blood clots during emergency heart attack treatment can reduce heart muscle damage. About 140 patients having a major heart attack will be randomly assigned to get either standard care or standard care plus clot removal. The main goal is to see if the clot removal group has less scarring and better heart function on MRI scans a few days later.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Thrombus aspiration with Indigo Aspiration System (CAT RX catheter)
- What this could lead to
- If successful, this could lead to a standard procedure to reduce heart muscle damage after a major heart attack, potentially improving long-term heart function.
- What could go wrong
- This is a relatively small, early-stage trial (140 patients) testing a device procedure. Previous studies on thrombus aspiration have shown mixed results, so it may not prove beneficial. Risks include procedural complications like vessel damage or stroke.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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IRCCS Ospedale San Raffaele
RECRUITINGMilan, Milani, 20132, Italy
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