NCT01493037

PICSO in Patients With STEMI Treated by Primary Percutaneous Coronary Intervention

Pressure Controlled Intermittent Coronary Sinus Occlusion in Patients With ST Segment Elevation Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention: Safety and Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Miracor Medical SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective multi-center study in which patients with an acute heart attack (in the left anterior descending artery) with ECG changes (ST segment elevation) receive angioplasty followed by stent placement and 90 minutes of PICSO treatment. This is a proof of concept study designed to document the safety and feasibility of the Pressure Controlled Intermittent Coronary Sinus Occlusion (PICSO) Impulse system.

Conditions

• ST Elevation (STEMI) Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	PICSO (Pressure-controlled Intermittent Coronary Occlusion	The PICSO catheter has a balloon which is placed in the coronary sinus via the femoral vein. The balloon is inflated and deflated at intervals calculated by an algorithm and adjusted according to the patient's own coronary sinus pressure plateau.

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-03-01
• First posted: 2011-12-15
• Last updated: 2014-07-16

Locations

2 sites across 1 country: Netherlands