Treatment (Compassionate) Use of Device - PK Papyrus (NCT05436470) | Clinical Trial Compass
TEMPORARILY_NOT_AVAILABLENot Applicable
Treatment (Compassionate) Use of Device - PK Papyrus
United States
Plain-language summary
The purpose of this study is to evaluate the clinical use of the PK Papyrus Coronary Stent Graft System, a Humanitarian Use Device (HUD) approved by the FDA under a Humanitarian Device Exemption.
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.
Exclusion criteria
. Patients from special populations including individuals who are not yet adults (infants, children, teenagers).
. Adults who are cognitively impaired, pregnant women, and prisoners.
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.
1Since this trial is listed as 'Temporarily Not Available,' can you find out when it might reopen, and should we be pursuing other treatment options for my pseudoaneurysm in the meantime?
2This is a compassionate use program rather than a standard clinical trial — can you explain what that means for my situation, and does it suggest that the PK Papyrus device isn't yet routinely approved for treating carotid pseudoaneurysms?
3What are the specific risks of using the PK Papyrus covered stent in a carotid artery pseudoaneurysm, and how do those risks compare to surgical repair or other endovascular options available to me right now?
4Given that this is a compassionate use program with no listed phase, what level of evidence exists about how well the PK Papyrus device works for pseudoaneurysms like mine, and are there published outcomes I should be aware of?
5If this program remains temporarily unavailable, are there other hospitals or centers where I might access this device or a similar treatment for a carotid pseudoaneurysm?
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.