A Study to Evaluate the Safety and Efficacy of PiCSO in Anterior STEMI Patients

NCT05497011 | Withdrawn FDA Device

• 1 other identifier: MIR-CIP 0003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to assess the safety and efficacy of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) as adjunct to percutaneous coronary intervention (PCI) compared to PCI in the setting of acute anterior ST-segment elevation myocardial infarction (STEMI).

Conditions

STEMI - ST Elevation Myocardial Infarction; Anterior Wall Myocardial Infarction

Keywords

PiCSO; PiCSO Impulse System

Outcome Measures

Primary Outcomes (2)

• 12% performance goal rate of PiCSO device or PiCSO procedure related adverse events reported through 30 days

  Primary safety endpoint is based on a 12% performance goal rate of PiCSO device or PiCSO procedure related adverse events reported through 30 days post treatment in patients randomized to PiCSO Group in which the PiCSO treatment was delivered or attempted to be delivered. These events will consist of the composite of: * Femoral venous access site complications: * Major bleed (BARC 3-5) * Infections requiring systemic (oral or intravenous) antibiotic treatment * Any femoral access site-related events requiring surgery * Coronary sinus dissection requiring percutaneous intervention or surgery * Pericardial effusion or tamponade requiring percutaneous intervention or surgery * Embolization or Thrombosis * Stroke

  30 days post index PCI

• Difference in myocardial infarct size

  Difference in myocardial infarct size (extent of myocardial necrosis quantified by delayed gadolinium enhancement presented as a percentage of left ventricular (LV) mass) between the PiCSO Group and the Control Group, assessed by CMR at 5±2 days post index PCI.

  5 days post index PCI

Secondary Outcomes (12)

• Major Adverse Cardiac Event (MACE) at 30 days as well as 1, 2 and 3 years post index PCI

  30 days, 1, 2 and 3 years post index PCI

• Individual components of the MACE

  30 days, 1, 2 and 3 years post index PCI

• Classification of all-cause death

  30 days, 6 months, 1, 2 and 3 years post index PCI

• Time to death and heart failure hospitalization

  1 year post index PCI

• Myocardial infarct size (% of LV mass) assessed by CMR at 6 months post index PCI

  6 months post index PCI

Study Arms (2)

Control

NO INTERVENTION

This is the actual control group receiving conventional therapy, ie. percutaneous coronary intervention.

PiCSO

EXPERIMENTAL

This arm will be treated with Pressure controlled intermittent Coronary Sinus Occlusion (PiCSO) in addition to conventional therapy (percutaneous coronary intervention).

Device: PiCSO Impulse System

Interventions

PiCSO Impulse System DEVICE

After blood flow restoration, the subjects meeting all eligibility criteria will be enrolled into the study and randomized either to PiCSO Group or Control Group. If the subject is randomized to PiCSO Group, the coronary sinus (CS) will be cannulated through the femoral vein and the PiCSO Impulse Catheter will be placed in the CS. Once PiCSO Impulse Catheter is placed into CS, PiCSO treatment is started followed by stenting. The physician shall target a PiCSO treatment of 45 minutes whereas the treatment should be continued during and post stent insertion. At the end of the PiCSO treatment, the PiCSO Impulse Console is stopped and the PiCSO Impulse Catheter is removed.

PiCSO

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
• Culprit lesion in proximal or mid left anterior descending artery (LAD)
• Pre-PCI TIMI flow 0, 1 or 2
• Symptoms onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h
• Electrocardiogram (ECG) evidence of acute anterior myocardial infarction with ST-elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial ECG leads (one of which should be V2, V3, or V4) in men or ≥ 1.5 mm (0.15 mV) in women
• Emergent PCI will be performed according to national and local hospital guidelines
• Consent per approved national IRB/EC specific requirements prior to the procedure.

You may not qualify if:

• Patient transferred from an outside hospital where invasive coronary procedure was attempted (including diagnostic catheterization)
• Implants or foreign bodies in the coronary sinus
• Left main disease \>= 50%
• Need for treatment of any vessel other than the LAD (or its branches) during the index procedure or before the 5 ± 2 days study CMR.
• Known allergy to polyurethanes, polyethylene terephthalate (PET) or stainless steel, both heparin and bivalirudin, or all of clopidogrel, ticagrelor or prasugrel that cannot be adequately pre-medicated
• Known pregnancy or breastfeeding
• Known large pericardial effusion or cardiac tamponade
• Known hemodynamically relevant left to right and right to left shunt
• Known previous myocardial infraction (MI)
• Previous coronary artery bypass graft (CABG)
• Known neurologic abnormality such as tumor or arteriovenous (AV) malformation, history of stroke within 6 months, any prior intracranial bleed or any permanent neurologic defect
• History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), any recent genitourinary (GU) or gastrointestinal (GI) bleed (within 3 months)
• Administration of fibrinolytic therapy within 24 hours prior to enrollment
• Cardiogenic shock (systolic blood pressure (SBP) \< 90 mmHg), need for mechanical circulatory support, intravenous pressor or pre-randomization intubation
• Patients with cardio-pulmonary resuscitated (CPR) cardiac arrest for more than 5 min or whom baseline neurologic status is not present

Sponsors & Collaborators

• Miracor Medical SA: lead

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Anterior Wall Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

• Gregg W. Stone, Prof.

  Mount Sinai, New York, US

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Prospective, multicenter, randomized, controlled, parallel-groups

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 11, 2022
• Study Start: March 30, 2023
• Primary Completion: July 31, 2025
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 24, 2023

Record last verified: 2023-03