Anterior Myocardial InfarctionTACTICNCT06887413
TACTIC Coronary Thrombus Aspiration With Cath Rx In Anterior Myocardial Infarction: A Randomized Control Trial.
A study testing THROMBOASPIRATION WITH INDIGO SYSTEM in people with Anterior Myocardial Infarction, run by Ceric Sàrl at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anterior Myocardial Infarction
- What is being tested?
- THROMBOASPIRATION WITH INDIGO SYSTEM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- 18 Feb 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 30Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Milani, 20132
Alaide Chieffo, +39 02.26431, cecalaide@gmail.com
About this study
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
- Conditions
- Anterior Myocardial Infarction
- Being tested
- THROMBOASPIRATION WITH INDIGO SYSTEM
- Keywords
- STEMI, thromboaspiration, anterior myocardial infarction, INDIGO CAT RX, indigo system, HEART ATTACK
- Medical subject headings
- Anterior Wall Myocardial Infarction, ST Elevation Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THROMBOASPIRATION WITH INDIGO SYSTEMProcedure or surgery
Subjects randomized to the treatment arm will be treated with the CAT RX as previously described.
| Study group | Role | What they receive |
|---|---|---|
| Subjects randomized to the control arm will be treated with standard PPCI | No intervention | Subjects randomized to the control arm will be treated with standard PPCI |
| - Treatment arm: Subjects randomized to the treatment arm will be treated with the CAT RX | Experimental | Treatment arm: Subjects randomized to the treatment arm will be treated with the CAT RX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular obstruction
Incidence of Microvascular obstruction (MVO) assessed by Cardiac Magnetic Resonance
Measured: Within 3-5 days post procedure
Secondary outcomes (4)
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)
Measured: Within 3-5 days post procedure
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
Measured: At the end of the procedure
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
Measured: At 1 year Follow Up
Safety endpoint
Incidence of device-related SAE(s) and Stroke
Measured: At 1 month post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start18 Feb 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Ceric SàrlThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ceric Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Responsible party
- Sponsor
- Investigators
- Alaide Chieffo, Principal investigator, San Raffaele Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887413
- Sponsor's protocol ID
- TACTIC
- Acronym
- TACTIC
- Status last verified
- Apr 2026
- First submitted
- 4 Mar 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TACTIC Coronary Thrombus Aspiration With Cath Rx In Anterior Myocardial Infarction: A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT06887413
- Acronym / sponsor ID
- TACTIC / TACTIC
- Conditions
- Anterior Myocardial Infarction
- Keywords
- STEMI, thromboaspiration, anterior myocardial infarction, INDIGO CAT RX, indigo system, HEART ATTACK
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ceric SàrlIndustry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects randomized to the control arm will be treated with standard PPCI | No intervention | –Subjects randomized to the control arm will be treated with standard PPCI |
| - Treatment arm: Subjects randomized to the treatment arm will be treated with the CAT RX | Experimental | –Treatment arm: Subjects randomized to the treatment arm will be treated with the CAT RX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (30 listed)
- Unable to give Informed consent.
- Life expectancy < 1 year.
- Contraindication to PCI
- STEMI due to stent thrombosis
- Spontaneous coronary aretery dissection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THROMBOASPIRATION WITH INDIGO SYSTEMSubjects randomized to the treatment arm will be treated with the CAT RX as previously described. | Procedure or surgery | – |
Primary outcome
Microvascular obstruction
Time frame: Within 3-5 days post procedure
Incidence of Microvascular obstruction (MVO) assessed by Cardiac Magnetic Resonance
4 secondary outcomes
Secondary CMR endpoint:
Time frame: Within 3-5 days post procedure
Secondary exploratory clinical and angiographic endpoint:
Time frame: At the end of the procedure
Safety endpoint
Time frame: At 1 year Follow Up
Safety endpoint
Time frame: At 1 month post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Prophylactic IABP in Delayed-Presentation Anterior STEMI
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Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alaide Chieffo principal investigator
San Raffaele Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THROMBOASPIRATION WITH INDIGO SYSTEM in people with Anterior Myocardial Infarction, run by Ceric Sàrl at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phani Krishna KONDAMUDI (+33 (0)1 60 11 17 91, pkondamudi@cerc-europe.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular obstruction (time frame: Within 3-5 days post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.