Treatment (Compassionate) Use of Device - PK Papyrus

University of Miami

Status

Conditions: Pseudoaneurysm; Pseudoaneurysm, Carotid

Treatments: Device: PK Papyrus

Study type: Expanded Access

Funder types: Other

Identifiers

NCT05436470

20220552

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.