PiCSO in ACS Study
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this research study is to find out whether PICSO (Pressure Controlled Coronary
      Sinus Occlusion), given concomitant to (NSTEMI) or following (STEMI) primary PCI and
      stenting, can improve final infarct size and myocardial function.

      ACS patients, NSTEMI and STEMI, with a culprit lesion in the LAD will be treated according to
      standard treatment, PCI followed by stent placement, with or without PICSO therapy. In NSTEMI
      patients, PICSO therapy will be given during PCI and stenting for a minimum of 30 minutes or
      the duration of the PCI and stent procedure. In STEMI patients PICSO therapy will be given
      after successful primary percutaneous coronary intervention of a left anterior descending
      coronary artery culprit lesion. PICSO therapy is initiated prior to stent deployment and
      continued during stenting. The functional efficacy measures, related to the PICSO duration
      and coronary sinus pressures, will be stored on the PICSO Impulse console and analysed
      offline. The clinical efficacy measures, cardiac enzyme release during 24 hour following PCI,
      cardiac function, infarct size and level of microvascular obstruction will be assessed by
      cMRI. Patients will be followed for a maximum of 4 months after the primary PCI procedure
    

Detailed description: 
      The study is designed to evaluate the effect of PICSO treatment concomitant to or following
      primary PCI in patients with anterior non ST-segment Elevation Myocardial Infarction or
      ST-segment Elevation Myocardial Infarction, in patients with a culprit lesion in the LAD on
      Infarct Size and myocardial function. There will be 2 phases in this study.

        1. Phase 1: only NSTEMI patients will be recruited.

        2. Phase 2: only STEMI patients will be recruited.

      Phase 1 During Phase 1 of the study only NSTEMI patients will be recruited. After having
      given informed consent the patient will be scheduled for pPCI and stent placement. On the day
      of the procedure the PICSO catheter will be placed as described below (refer to PICSO Impulse
      catheter placement). After the PICSO therapy is started the standard pPCI and stent placement
      is performed. PICSO is continued at a minimum of 30 minutes or as long as the standard pPCI
      and stent placement takes.

      Phase 2 During Phase 2 of the study only STEMI patients will be recruited. Immediately after
      successful restoration of the blood flow the PICSO Impulse catheter is introduced and placed
      as described below (Refer to PICSO Impulse catheter placement).

      After correct positioning of the PICSO Impulse catheter, the 0,032" guide wire is removed.
      PICSO therapy is initiated and continued until a PICSO Quantity of 1000 mmHg is reached or a
      maximum of 60 minutes active treatment whatever comes first. With PICSO in treatment mode,
      the stent is deployed.

      The clinical outcome data collected will be based on the site standards of care for NSTEMI
      and acute STEMI. Examinations include but are not limited to physical assessments, cardiac
      markers, ECG, laboratory results, x-rays, angiograms, cMRI and echocardiography.
    

Intervention name(s): PICSO
Intervention type(s): Device
Intervention description(s): Pressure controlled Intermittent Coronary Pressure Occlusion
Other intervention name(s): PICSO Impulse System
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NSTEMI and STEMI