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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 | Eligibility | Citations | Contacts

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.

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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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Robert J. Lederman, M.D.
National Heart, Lung and Blood Institute (NHLBI)
NIHBC 10 - CLINICAL CENTER BG RM 2C713
10 CENTER DR
BETHESDA MD 20892
(301) 402-6769
lederman@nih.gov

Robert J. Lederman, M.D.
National Heart, Lung and Blood Institute (NHLBI)
NIHBC 10 - CLINICAL CENTER BG RM 2C713
10 CENTER DR
BETHESDA MD 20892
(301) 402-6769
lederman@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

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