ClinicalTrials.gg
RecruitingNCT06887413TACTICUpdated Apr 21, 2026

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

An interventional study of THROMBOASPIRATION WITH INDIGO SYSTEM in Anterior Myocardial Infarction, sponsored by Ceric Sàrl. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by Ceric Sàrl · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

Read the detailed 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

02

Conditions studied

  • Anterior Myocardial Infarction

Keywords

  • STEMI
  • thromboaspiration
  • anterior myocardial infarction
  • INDIGO CAT RX
  • indigo system
  • HEART ATTACK
03

In context

Anterior Wall Myocardial Infarction

36 studies on the registry are indexed under Anterior Wall Myocardial Infarction; 5 are open to participants now.

This study's planned enrollment of 140 is above the median of 110 across 28 interventional studies indexed under Anterior Wall Myocardial Infarction.

Browse Anterior Wall Myocardial Infarction studies →

Lead sponsor

Ceric Sàrl is the lead sponsor of 17 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

EXCLUSION CRITERIA

  1. Unable to give .
  2. \< 1 year.
  3. 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. (COPD) with home oxygen therapy or on chronic therapy
  6. Contraindication to perform MRI or use gadolinium [ (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/ within 3 months prior to screening
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • No intervention
    Subjects randomized to the control arm will be treated with standard PPCI

    Subjects randomized to the control arm will be treated with standard PPCI

  • Experimental
    - Treatment arm: Subjects randomized to the treatment arm will be treated with the CAT RX

    Treatment arm: Subjects randomized to the treatment arm will be treated with the CAT RX

Interventions

  • ProcedureTHROMBOASPIRATION WITH INDIGO SYSTEM

    Subjects randomized to the treatment arm will be treated with the CAT RX as previously described.

06

What researchers measure

Primary outcomes

  1. Microvascular obstruction

    Incidence of Microvascular obstruction (MVO) assessed by Cardiac Magnetic Resonance

    Time frame: Within 3-5 days post procedure

Secondary outcomes

  1. Secondary CMR endpoint:

    Left Ventricular Mass in % 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)

    Time frame: Within 3-5 days post procedure

  2. Secondary exploratory clinical and angiographic endpoint:

    Incidence of TIMI 3 flow at the end of primary PCI Post PCI non-hyperemic angio-derived IMR measurements. PCI

    Time frame: At the end of the procedure

  3. Safety endpoint

    Incidence of 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

    Time frame: At 1 year Follow Up

  4. Safety endpoint

    Incidence of device-related SAE(s) and Stroke

    Time frame: At 1 month post procedure

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2026 (actual). Primary completion is estimated for Feb 2027, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 4, 2025
First posted
Mar 20, 2025
StartActual
Feb 18, 2026
Primary completionEst.
Feb 28, 2027
CompletionEst.
May 31, 2027
Last update
Apr 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06887413
Lead sponsor
Ceric Sàrl
Collaborators
European Cardiovascular Research Center
Responsible party
Sponsor
First posted
Mar 20, 2025
Start date
Feb 18, 2026
Primary completion
Feb 28, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Apr 21, 2026

Study contacts

Phani Krishna KONDAMUDI
Contact
pkondamudi@cerc-europe.org
+33 (0)1 60 11 17 91
Alaide Chieffo
principal investigator · San Raffaele Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion