Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05497011

A Study to Evaluate the Safety and Efficacy of PiCSO in Anterior STEMI Patients — PiCSO-AMI-II  

STEMI - ST Elevation Myocardial Infarction Clinical Trial

Official title:
A Randomized Controlled Study to Evaluate the Safety and Efficacy of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Anterior STEMI Patients With TIMI 0-2 at Presentation.

Clinical Trial 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).

Clinical Trial Description

This is a multicenter, randomized (2 PiCSO :1 Control), controlled, pivotal study to evaluate safety and feasibility of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy in patients with acute anterior ST-segment elevation myocardial infarction (STEMI), presenting with thrombolysis in myocardial infarction (TIMI) 0, 1, or 2 and symptom duration ≤ 12 hours treated adjunct to PCI compared to standard PCI. Patients with an ST-segment elevated anterior infarct eligible for PCI will be invited to participate in the PiCSO-AMI-II anterior STEMI study. After consent as per approved ethics committee requirements, baseline assessments will be performed. PCI of the culprit vessel should be performed per standard practices. After TIMI 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. In the event the PiCSO Impulse Catheter cannot be placed in the CS within 30 minutes, the physician should proceed with the regular PCI and the PiCSO treatment will be considered a failure. 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. The patient is seen at 5 days and 6 months for cardiovascular magnetic resonance imaging (CMR). Follow-up visits will take place at day 5, day 30, 6 months, 1 year, 2 years and 3 years. At every follow-up visit safety data and health status will be documented. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05497011
Study type Interventional
Source Miracor Medical SA
Contact
Status Withdrawn
Phase N/A
Start date March 30, 2023
Completion date June 30, 2028
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06013813 - Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI N/A
Terminated NCT04542889 - Coronary Microcirculation Assessment After Primary Angioplasty in Myocardial Infarction N/A
Recruiting NCT04951856 - Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to PCI Phase 4
Terminated NCT04459299 - CorPath GRX STEMI Study
Recruiting NCT05557019 - Semi Occlusion of the Coronary Sinus as an Adjunct to PCI in STEMI Patients, FIH Clinical Study N/A
Completed NCT03527940 - Prognostic Markers of Patients With STEMI
Not yet recruiting NCT03264859 - NGAL and Its Association With the No-reflow Phenomenon in ST-elevation Myocardial Infarction N/A
Not yet recruiting NCT03182855 - Cangrelor vs. Ticagrelor for Early Platelet Inhibition in STEMI Phase 4
Not yet recruiting NCT03266289 - Evaluation of Short Term Outcome of Different Bifurcation Stenting Techniques at Assuit University Cath. Lab N/A
Withdrawn NCT04566289 - Observational Registry to Evaluate Real World Usage of PiCSO Impulse System in STEMI Patients as Part of Post-marketing Surveillance
Completed NCT04289012 - HELicobacter Pylori Screening in Patients With Acute Myocardial Infarction Pilot Study N/A
Not yet recruiting NCT04185077 - Bivalirudin in Late PCI for Oatients With STEMI Phase 4
Completed NCT03609346 - Asian Registry of the BioFreedom Stent for STEMI Patients
Recruiting NCT05107076 - Effect of PPCI on Diastolic Function & Levels of Galactin-3 in Patients With STEMI
Recruiting NCT02998853 - Non Culprit Functional Evaluation With 3D Angio QFR in STEMI PCI Procedure N/A
Completed NCT03677180 - National Cardiogenic Shock Initiative
Completed NCT03507777 - ILUMIEN IV: OPTIMAL PCI N/A
Recruiting NCT03863327 - EKG Criteria and Identification of Acute Coronary Occlusion
Completed NCT03070496 - Multicenter Cohort of STEMI Patients N/A
Active, not recruiting NCT03874338 - CLEAR SYNERGY Neutrophil Substudy