Effects of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) Therapy on miRNAs Expression and Absolute Microvascular Resistance by Continuous Thermodilution in ST-segment Elevation Myocardial Infarction (STEMI) Patients: PiCSO-STEMI TRIAL

NCT05644925 | Withdrawn DMC

• 1 other identifier: PiCSO-STEMI
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study we pretend to determine the molecular (miRNAs expression, angiogenic and inflammatory biomarkers) and microcirculatory (assessed by the innovative continuous intracoronary thermodilution technique) effects of PiCSO compared to a standard PCI control group in patients with high-risk anterior STEMI. Then, we aim to assess the efficacy of these molecular biomarkers as prognostic tools. Also, we will evaluate the impact of PiCSO on the coronary microcirculation beyond the acute phase in the follow-up six months after STEMI. Finally, we will assess PiCSO influence on Heart Failure (HF) clinical variables and patients' quality of life including a cost-effectiveness assessment in the mid-term follow-up one year after the STEMI event.

Conditions

Anterior Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Superiority of PiCSO in reducing microvascular dysfunction

  To determine the superiority of PiCSO in reducing the microvascular dysfunction (defined as microvascular resistance \>500 WU) as compared to standard of care

  After primary PCI at time 0 after intervention

Study Arms (2)

PICSO+PCI

EXPERIMENTAL

Device: PiCSO Impulse System; Procedure: Percutaneous Coronary Intervention (PCI)

Standard PCI

ACTIVE COMPARATOR

Procedure: Percutaneous Coronary Intervention (PCI)

Interventions

PiCSO Impulse System DEVICE

The PiCSO Impulse System is intended to reduce infarct size by intermittently occluding the coronary sinus outflow in patients undergoing a percutaneous coronary interventional procedure for myocardial infarction and presenting with Thrombolysis in myocardial infarction (TIMI) flow of 0 or 1.

PICSO+PCI

Percutaneous Coronary Intervention (PCI) PROCEDURE

Minimally invasive procedures used to open clogged coronary arteries

PICSO+PCI; Standard PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old.
• Anterior STEMI (ECG with persistent elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial leads (V2, V3, V4) in men or ≥ 1.5 mm (0.15 mV) in women.
• Culprit lesion in proximal or mid Left Anterior Descending Artery (LAD).
• Pre-PCI TIMI flow 0-1.
• Symptoms consistent with myocardial ischemia (persistent chest pain, dyspnea, nauseas/vomiting, fatigue, palpitations or syncope) present for ≤ 12 hours.
• The patient is eligible for primary PCI.
• Informed consent received and signed for study enrollment.

You may not qualify if:

• Contraindication to coronary angiogram or PCI.
• Implants or foreign bodies in the coronary sinus.
• Known allergies to polyurethanes, Polyethylene Terephthalate (PET) or stainless steel.
• Known pregnancy or breastfeeding.
• Known coagulopathy.
• Known severe kidney disease (eGFR \<=30 mL/min/1.73) and/or hemodialysis.
• Known large pericardial effusion or cardiac tamponade.
• Central hemodynamically relevant left-right shunt.
• Previous MI or Coronary Artery Bypass Graft (CABG).
• Previous history of stroke, transient ischemic attack (TIA) or reversible ischemic neurological deficit within last 6 months.
• Cardiopulmonary resuscitated (CPR) cardiac arrest ≥ 5 minutes whom baseline neurologic status is not present.
• Unconscious at presentation.
• Need for circulatory support.
• Need for invasive mechanical ventilation.
• Need for temporal intravenous pacemaker.

Sponsors & Collaborators

• Fundacio Privada Mon Clinic Barcelona: lead
• Miracor Medical SA: collaborator

MeSH Terms

Conditions

Anterior Wall Myocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The subjects as well as the investigator performing the procedure will not be blind to the study treatment. An independent experienced cardiologist, who will be blinded to all clinical data; will analyze anonymized Cardiac Magnetic Resonance (CMR) images for unbiased endpoints assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized (1:1) to PiCSO group or standard PCI control group. Once randomized, PiCSO group patients will receive PiCSO therapy inside the catheterization laboratory.

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 9, 2022
• Study Start: November 14, 2022
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share