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NCT05436470 Clinical Trial

Treatment (Compassionate) Use of Device - PK Papyrus

Pseudoaneurysm Clinical Trial

Official title:
Treatment (Compassionate) Use of Device - PK Papyrus

Clinical Trial Details — Status: Temporarily not available

Administrative data
NCT number NCT05436470
Other study ID # 20220552
Secondary ID
Status Temporarily not available
Phase
First received
Last updated

Study information
Verified date June 2023
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical 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.

Recruitment information / eligibility
Status Temporarily not available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 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. Exclusion Criteria: 1. Patients from special populations including individuals who are not yet adults (infants, children, teenagers). 2. Adults who are cognitively impaired, pregnant women, and prisoners.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• PK Papyrus
The PK Papyrus is a balloon mounted stent that will be administered during standard of care treatment of pseudoaneurysms.

Locations
Country Name City State
United States Jackson Memorial Hospital Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

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