Pseudoaneurysm, CarotidNCT05436470
Treatment (Compassionate) Use of Device - PK Papyrus
A study testing PK Papyrus in people with Pseudoaneurysm, Carotid and Pseudoaneurysm, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudoaneurysm, Carotid, Pseudoaneurysm
- What is being tested?
- PK Papyrus
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 1. Patients with traumatic, dissecting, pseudo, or other wide based aneurysms in non-perforator territories or fistulas of the extracranial or intracranial segments of the internal carotid or vertebral artery.
Who cannot join
- Patients from special populations including individuals who are not yet adults (infants, children, teenagers).
- Adults who are cognitively impaired, pregnant women, and prisoners.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pseudoaneurysm, Carotid, Pseudoaneurysm
- Being tested
- PK Papyrus
- Medical subject headings
- Carotid Artery Injuries, Aneurysm, False
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PK PapyrusDevice
The PK Papyrus is a balloon mounted stent that will be administered during standard of care treatment of pseudoaneurysms.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudoaneurysm, CarotidStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Starke, University of Miami
- Investigators
- Robert Starke, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436470
- Sponsor's protocol ID
- 20220552
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2022
- Last updated
- 17 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment (Compassionate) Use of Device - PK Papyrus
- ClinicalTrials.gov ID
- NCT05436470
- Acronym / sponsor ID
- 20220552
- Conditions
- Pseudoaneurysm, Carotid, Pseudoaneurysm
- Study type
- Expanded access
- Recruitment status
- Temporarily Not Available
- Lead sponsor
- University of MiamiUniversity, hospital or other
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients with traumatic, dissecting, pseudo, or other wide based aneurysms in non-perforator territories or fistulas of the extracranial or intracranial segments of the internal carotid or vertebral artery.
Key exclusion criteria (2 listed)
- Patients from special populations including individuals who are not yet adults (infants, children, teenagers).
- Adults who are cognitively impaired, pregnant women, and prisoners.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PK PapyrusThe PK Papyrus is a balloon mounted stent that will be administered during standard of care treatment of pseudoaneurysms. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Starke, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PK Papyrus in people with Pseudoaneurysm, Carotid and Pseudoaneurysm, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.