Protocol Details
NHLBI DIR Cardiovascular Branch PK Papyrus Covered Stent Ethics Oversight of Humanitarian Use Device for Treatment of Acute Perforations of Native Coronary Arteries and Coronary Bypass Grafts in Vessels 2.5 to 5.0 mm in Diameter
This study is currently recruiting participants.
Summary
Number |
20-H-0049 |
Sponsoring Institute |
National Heart, Lung and Blood Institute (NHLBI) |
Recruitment Detail |
Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A |
Referral Letter Required |
Yes |
Population Exclusion(s) |
Children |
Keywords |
Humanitarian Use Device |
Recruitment Keyword(s) |
None |
Condition(s) |
Coronary Disease |
Investigational Drug(s) |
None |
Investigational Device(s) |
PK Papyrus Covered Coronary Stent System
|
Intervention(s) |
Device: PK Papyrus coronary artery stent
|
Supporting Site |
National Heart, Lung, and Blood Institute |
Background:
Percutaneous coronary artery intervention is a nonsurgical procedure. It uses a catheter to place a stent in a blood vessel of the heart. A stent is a small tube that opens up blood vessels that have been narrowed by plaque buildup. Sometimes the blood vessel is pierced with a hole while the stent is being placed. This is rare but must be treated quickly to prevent harm or death. A Humanitarian Use Device (HUD) is a device that is not used often and does not have premarket approval, but it can help save lives. The PK Papyrus is a covered stent. It is a HUD. Researchers think that it may help fix the hole that is made.
Objective:
To give independent ethics oversight of a HUD called the PK Papyrus covered stent.
Eligibility:
Adults who need to be treated for acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter
Design:
This study allows the PK Papyrus covered stent to be implanted in a participant if a hole is made in a blood vessel of the heart during percutaneous coronary artery intervention.
Physicians will try to implant the PK Papyrus covered stent if the attending physician thinks it could work.
The stent will be implanted across the site of the hole. It will be placed against the wall of the blood vessel to immediately stop the flow of blood.
The participant s involvement in the study ends after implantation is attempted.
Eligibility
INCLUSION CRITERIA:
-Patients suffering acute perforation of appropriately sized native coronary arteries or coronary artery bypass grafts
INCLUSION OF VULNERABLE PARTICIPANTS:
-Decisionally Impaired Adults: Subjects undergoing a coronary artery intervention will be under sedation during the procedure. In the event the PK Papyrus stent is ever used, these subjects will not be aware of the device use until after completion of the intervention. Please note that this intervention is not considered research.
EXCLUSION CRITERIA:
No exclusion criteria are provided because the alternative to treatment with the PK Papyrus covered stent, when indicated, is typically death.
Citations:
Not Provided
Contacts: