Observational Registry to Evaluate Real World Usage of PiCSO Impulse System in STEMI Patients as … (NCT04566289) | Clinical Trial Compass
WithdrawnNot Applicable
Observational Registry to Evaluate Real World Usage of PiCSO Impulse System in STEMI Patients as Part of Post-marketing Surveillance
Stopped: Study terminated due to lack of financing
Germany0Started 2022-10-01
Plain-language summary
A prospective, multicenter, single-arm, open label registry of commercially treated patients with PiCSO Impulse System.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years old
. Culprit lesion in proximal or mid LAD
. ST-segment elevation
. Pre-PCI TIMI flow 0 or 1.
. Symptoms onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h.
. Patient is deemed eligible for PCI
. Consent as per approved national ethical committee specific requirements prior to the procedure.
Exclusion criteria
. Patients with contraindications to percutaneous insertion or angiography
. Patients with implants or foreign bodies in the coronary sinus
. Known allergy to polyurethanes, PET or stainless steel
. Known pregnancy or breast feeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse Device Effect (ADE) rate at 30 days post index procedure PCI