• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

Learn more...


             

Relay Thoracic Stent-Graft w Plus Del Sys


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Adequate
Application Number P110038 / PAS001
Date Current Protocol Accepted 02/06/2018
Study Name Relay Thoracic Stent-Graft w Plus Del Sys
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a multi-center observational prospective cohort study.
Study Population Description This population will consist of 120 Relay Phase II subjects and 13 Relay Continued Access study subjects plus 45 subjects treated post-approval with the Relay Thoracic Stent-Graft at centers which did not participate in the premarket studies.

Sample Size A sample size of 178 patients is based on the desire to have adequate follow up at 5-years to assess the primary endpoint assuming 20% attrition through thevfollow-up period. The sample size will include: 120 from Phase II study, 13 continued access subjects, and 45 subjects enrolled post-approval at a maximum of 30 sites which did not participate in the pre-marekt Relay studies, including Phase I feasiblity.

Data Collection The primary endpoint is measured as freedom from ARM at 5 years post- procedure. Aneurysm-related mortality is defined as death from rupture of the descending thoracic aortic aneurysm (DTAA) or penetrating aortic ulcer (PAU), or from any procedure intended to treat the DTAA or PAU. If a death occurred within 30 days of any procedure intended to treat the DTAA or PAU, or within the hospital stay if the patient was not discharged within 30 days, then it is presumed to be aneurysm-related.

Two secondary endpoints for this trial are the assessment of training effectiveness and the evaluation of major device-related events and major morbidity.

Training effectiveness will be assessed by comparing the following:

Delivery and deployment results of subjects treated by novice implanters of the Relay Thoracic Stent-Graft with Plus Delivery System (subjects enrolled in this study) to delivery and deployment results from the Relay Clinical Trial IP-0004-06

Survival, freedom from rupture, freedom from conversion, and number of endoleaks (Type I, III, and IV only) at 30 days post-implantation for the novice implanters’ first three implantations to those of the first three implantations of experienced implanters.

Major device-related events include the following: aneurysm rupture, increase in aneurysm sac size, conversion to open surgery, endoleak (Type I, III and IV only), stent migration (migration greater than or equal to 10 mm as compared to the 1-month visit), wireform fracture, and lumen occlusion.

Major morbidity is a composite of the following major adverse events. These events are considered by definition to be serious in nature.

Stroke (defined as a sudden, non-convulsive loss of neurological function due to an ischemic or hemorrhagic intracranial vascular event);

Paralysis / Paraplegia (defined as loss of power or voluntary movement in a muscle through injury to or disease of its nerve supply within 30 days of the procedure. Paraplegia is paralysis of both lower extremities, and generally lower trunk, within 30 days of the procedure);

Myocardial Infarction (defined as an acute episode in which circulation to a region of the heart is obstructed and necrosis is occurring; it is usually characterized by severe pain, frequently associated with pallor, perspiration, nausea, dyspnea, and dizziness; electrographic abnormalities may include Q wave ST segment, and T wave alterations);

Respiratory Failure (defined as a need for mechanical ventilation beyond the first 48 hours after the procedure or the need for reintubation or ventilator support any time between 48 hours and 30 days postoperative);

Renal Failure (defined as rise in creatinine greater than 50% above the pre- procedure level resulting in a creatinine level above high normal that does not spontaneously resolve and requires dialysis treatment); and

All-Cause Mortality.



Follow-up Visits and Length of Follow-up 5 years

1 month, 1 year, and annually thereafter



Relay Thoracic Stent-Graft w Plus Del Sys Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/22/2013 05/06/2013 Overdue/Received
one year report 09/21/2013 09/19/2013 On Time
18 month report 04/30/2014 04/30/2014 On Time
two year report 09/21/2014 09/09/2014 On Time
three year report 09/21/2015 07/28/2015 On Time
42 month report 03/21/2016 03/21/2016 On Time
four year report 09/20/2016 09/21/2016 Overdue/Received
five year report 09/20/2017 10/02/2017 Overdue/Received
six year report 09/20/2018 09/21/2018 Overdue/Received
seven year report 09/20/2019    
eight year report 09/21/2020    
nine year report 09/20/2021    
ten year report 09/20/2022    
final report 12/22/2023    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

Related Links

-
-