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Notification of Clinical Investigation Approved Under Exception from Informed Consent Regulations (21 CFR 50.24) Introduction Percutaneous coronary intervention (PCI) is a non-surgical procedure to treat many types of heart issues using thin flexible tubes (catheters), guidewires (wires that are used as a guide to place other medical devices), and stents (small structures to prop open the blood vessel). A clinical investigation is being conducted at Piedmont Healthcare to study a new medical device that is related to a potential complication of PCI. Exception from Informed Consent Written informed consent is usually required before a patient can be enrolled in a clinical investigation. Under special laws for emergency research (called "exception from informed consent"), patients can be enrolled in a clinical investigation without their consent if certain criteria are met. Exception from informed consent laws apply when: A patient is in a life-threatening emergency, and it is not possible to obtain informed consent There is no reasonable way to identify who would likely meet the criteria for the clinical investigation The clinical investigation could not be carried out without the special laws This clinical investigation is being conducted according to the exception from informed consent laws. When possible, informed consent will be obtained before a patient is enrolled in the clinical investigation. Request for Input The exception from informed consent laws require the sponsor of the clinical investigation to tell the community about this emergency research clinical investigation, listen for concerns, and address to those concerns. Please visit the website below to learn more about the clinical investigation treatment procedure, the investigational medical device, the exception from informed consent law, and patient costs that may occur if you participate in this clinical investigation. Please use the contact information below to ask questions or share your concerns about this emergency research clinical investigation. Sherry Lane, Sr. Regulatory Scientist, Teleflex Email: Phone: 612-499-3531 Shelby Radek, Clinical Research Analyst, Piedmont Research Institute Email: Phone: 404-605-4197 Opting Out If you do not wish to participate in the clinical investigation, information on opting out is also available from the website or through the contact information above. Caution INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE 10-30-22
October 30, 2022
November 28, 2022
November 28, 2022 8:10pm