Trials / Temporarily Not Available
Temporarily Not AvailableNCT05436470
Treatment (Compassionate) Use of Device - PK Papyrus
- Status
- Temporarily Not Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- University of Miami · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PK Papyrus | The PK Papyrus is a balloon mounted stent that will be administered during standard of care treatment of pseudoaneurysms. |
Timeline
- First posted
- 2022-06-29
- Last updated
- 2025-06-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05436470. Inclusion in this directory is not an endorsement.