NCT05644925

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fundacio Privada Mon Clinic Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	PiCSO Impulse System	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.
PROCEDURE	Percutaneous Coronary Intervention (PCI)	Minimally invasive procedures used to open clogged coronary arteries

Timeline

• Start date: 2022-11-14
• Primary completion: 2024-06-21
• Completion: 2024-06-21
• First posted: 2022-12-09
• Last updated: 2025-08-14