Treatment (Compassionate) Use of Device - PK Papyrus
Sponsor
University of Miami (Other)
Overall Status
Temporarily not available
CT.gov ID
NCT05436470
Collaborator
(none)
1
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Expanded Access
Official Title:
Treatment (Compassionate) Use of Device - PK Papyrus
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
- 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.
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jackson Memorial Hospital | Miami | Florida | United States | 33136 |
Sponsors and Collaborators
- University of Miami
Investigators
- Principal Investigator: Robert Starke, MD, University of Miami
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Robert Starke,
Associate Professor,
University of Miami
ClinicalTrials.gov Identifier:
NCT05436470
Other Study ID Numbers:
- 20220552
First Posted:
Jun 29, 2022
Last Update Posted:
Jun 29, 2022
Last Verified:
Jun 1, 2022