Essential Pro PMCF Study ( rEPIC04E ) (NCT05292092) | Clinical Trial Compass
CompletedNot Applicable
Essential Pro PMCF Study ( rEPIC04E )
Spain161 participantsStarted 2022-09-26
Plain-language summary
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Essential Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Essential Pro.
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:
* Patient treated with Essential Pro according to routine hospital practice and following instructions for use
* Informed consent signed
Exclusion Criteria:
• Not meet inclusion criteria
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.
1This trial is a post-market study tracking a coronary stent already approved for use — can you explain what 'freedom from Target Lesion Failure' means in practical terms, and what it would mean for my artery if that outcome wasn't achieved?
2Since this study has already completed, has any of the safety data from it been published or reviewed, and does it change your thinking about recommending this type of stent for my situation?
3This trial focused on coronary artery disease and ischemic heart disease — given my specific diagnosis, how does the lesion or artery they were studying in this trial compare to what's going on in my heart?
4Because this was a post-market follow-up study rather than a randomized controlled trial, how confident can we be in the safety findings, and are there other studies you'd want me to look at alongside this one?
5Are there standard treatment options or other stent technologies we should compare against the device studied in this trial before deciding on the best approach for me?
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
Safety Endpoint. Freedom from Target Lesion Failure