TEMPORARILY_NOT_AVAILABLENot Applicable

Treatment (Compassionate) Use of Device - PK Papyrus

United States

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

Trial details

NCT IDNCT05436470

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeEXPANDED_ACCESS

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