PK Papyrus Covered Coronary Stent System; H170004
Enrolling By Invitation
99 years and younger
All
Phase
N/A
100 participants needed
1 Location
Brief description of study
The PK Papyrus Covered Coronary Stent System (PK Papyrus) received approval under a Humanitarian Device Exemption (HDE H170004) from the Food and Drug Administration on September 14, 2018 and is only indicated for treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter.
Detailed description of study
The PK Papyrus Covered Coronary Stent System is a balloon-expandable covered stent that is pre-mounted on a fast-exchange delivery system. The stent is intended for permanent intraluminal placement in the coronary arteries to treat acute coronary artery perforations.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
-
Age: - 99 Years
-
Gender: All
Updated on
09 Oct 2024.
Study ID: 856507
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