NCT06887413

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Feb 2026May 2027

First Submitted

Initial submission to the registry

March 4, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

February 18, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

March 4, 2025

Last Update Submit

April 16, 2026

Conditions

Anterior Myocardial Infarction

Keywords

STEMIthromboaspirationanterior myocardial infarctionINDIGO CAT RXindigo systemHEART ATTACK

Outcome Measures

Primary Outcomes (1)

  • Microvascular obstruction

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

    Within 3-5 days post procedure

Secondary Outcomes (4)

  • Secondary CMR endpoint:

    Within 3-5 days post procedure

  • Secondary exploratory clinical and angiographic endpoint:

    At the end of the procedure

  • Safety endpoint

    At 1 year Follow Up

  • Safety endpoint

    At 1 month post procedure

Study Arms (2)

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

Interventions

THROMBOASPIRATION WITH INDIGO SYSTEMPROCEDURE

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Milani, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Anterior Wall Myocardial InfarctionST Elevation Myocardial InfarctionMyocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Alaide Chieffo

    San Raffaele Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Phani Krishna KONDAMUDI

CONTACT

+33 (0)1 60 11 17 91pkondamudi@cerc-europe.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 20, 2025

Study Start

February 18, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)