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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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.

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ODE Lead-Cont f/u of premarket cohorts w/stent fra


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General
Study Status Progress Adequate
Application Number P150028 / PAS002
Date Current Protocol Accepted  
Study Name ODE Lead-Cont f/u of premarket cohorts w/stent fra
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study should include all currently enrolled and alive patients in the COAST and COAST II studies with stent fractures and COAST CAP and COAST II CAP studies with stent fractures who had completed 2-year follow-up at the time of PMA submission.



The objective of this study is to evaluate the long-term safety and effectiveness of the CP Stents and Covered CP Stents in patients with stent fractures through ten years post-implant.

Study Population Description This study should include all currently enrolled and alive patients in the COAST and COAST II studies with stent fractures and COAST CAP and COAST II CAP studies with stent fractures who had completed 2-year follow-up at the time of PMA submission.
Sample Size The following describes each study from which the patients will be selected, based on the presence of stent fractures, as described in the Study Population section above:



COAST:

112 safety cohort patients, 105 effectiveness cohort patients

The trial will be considered a success if the hypotheses relating to all four primary outcomes are confirmed.

Primary Safety:

1) Occurrence of any serious or somewhat serious adverse event attributed to the stent or implantation procedure within 30 days of the catheterization procedure.

2) Occurrence of post-procedure paradoxical hypertension.

Primary Effectiveness:

1) Reduction in arm-leg systolic blood pressure gradient from pre-dilation to the 12 month post-dilation follow-up.

2) Length of stay in the hospital, measured in days.

The following table from the COAST Protocol V4 displays the power calculations and assumptions associated with each primary outcome.





COAST CAP:

Total of 16 possible patients in safety and effectiveness cohorts. Only 8 patients completed 2 year follow-up at the time of the PMA submission. Two stent fractures were observed in the COAST CAP, representing 16.7% of the subjects. There was loss of structural integrity in one patient. These two patients would likely be included in the PAS.



COAST II:

82 patients enrolled for safety cohort and effectiveness cohort

The trial will be considered a success if the hypotheses relating to all primary outcomes are confirmed.

Primary Safety: Occurrence of any serious or somewhat serious adverse event attributed to the stent or implantation procedure within 30 days of the catheterization procedure.

Primary Effectiveness:

1) Improvement of aortic wall injury and/or aortic arch obstruction by a median increase of at least one grade from pre-implantation baseline to 12-month follow-up using the Severity of Illness Scale (based on upper extremity (UE) systolic BP, UE to lower extremity (LE) systolic BP, and aortic wall injury).

2) Aortic wall injury and aortic arch obstruction at Grade 4 or above at the 12-month follow-up, based on the Severity of Illness Scale, with no clinical worsening.

The following table from the COAST II Protocol V2 displays the power calculations and assumptions associated with each primary outcome.





COAST II CAP:

Total of 45 possible patients in the safety and effectiveness cohorts. Only 16 patients completed 2-year follow-up at the time of the PMA submission. One stent fracture was observed in the COAST II CAP, which did not result in loss of structural integrity. This patient would likely be included in the PAS.

Data Collection COAST:

Primary Safety Endpoint #1: Occurrence of any serious or somewhat serious adverse event attributed to the stent or implantation procedure within 30 days of the catheterization procedure.

Primary Safety Endpoint #2: Occurrence of post-procedure paradoxical hypertension.

Primary Effectiveness Endpoint #1: Reduction in arm-leg systolic blood pressure gradient from pre-dilation to the 12-month post-dilation follow-up.

Primary Effectiveness Endpoint #2: Length of stay in the hospital, measured in days



COAST CAP:

The primary safety endpoints were the occurrence of device or implant related serious adverse events and the occurrence of post-procedure paradoxical hypertension. The primary effectiveness endpoints were reduction in arm-leg systolic blood pressure gradient and length of stay in the hospital.



COAST II:

Primary Safety Endpoint: Occurrence of any serious or somewhat serious adverse event attributed to the stent or implantation procedure within 30 days of the catheterization procedure.

Secondary Safety Endpoint: Proportion of patients experiencing any of the following adverse events related to the device or implant procedure post 1 year

? Underlying cardiac or non-cardiac disease, aortic wall injury, new aortic aneurysm formation within region of device, stent misplacement, malposition, stent fracture, aortic wall aneurysms, or restenosis requiring reintervention.

Primary Effectiveness Endpoint #1: Improvement of aortic wall injury and/or aortic arch obstruction by a median increase of at least one grade from pre-implantation baseline to 12-month follow-up using the Severity of Illness Scale (based on upper extremity (UE) systolic BP, UE to lower extremity (LE) systolic BP, and aortic wall injury).

Primary Effectiveness Endpoint #2: Aortic wall injury and aortic arch obstruction at Grade 4 or above at the 12-month follow-up, based on the Severity of Illness Scale, with no clinical worsening.



COAST II CAP:

The primary safety endpoint was the occurrence of device- or procedure- related serious adverse events. The primary effectiveness endpoint was improvement of aortic wall injury and/or aortic arch obstruction.



In addition, the FDA requested reporting of the following outcomes annually:

Blood pressure outcomes:

i. Percent of patients with:

1. Systolic blood pressure (SBP) arm-leg differences under 20, 15 and 10 mmHg;

2. Average arm?leg SBP difference; and

3. Proportion of patients with hypertension.



b. Aortic Wall Injury (AWI) Outcomes:

i. Clinical summaries for any patient with new or progressive AWI requiring follow-up imaging, intervention or surgery (imaging performed on a clinical basis ? descriptive summary only); and

ii. Overall incidence of patients detected with new or progressive AWI (using baseline sample size as denominator).



c. Stent Fracture Outcomes:

i. Any new or progressive stent fracture;

ii. Total incidence of stent fracture for bare metal and covered stents (using baseline sample size as denominator);

iii. Descriptive summaries for each stent fracture, including need for re-intervention or surgery; and

iv. Total incidence and types of late sequelae (e.g., none, recoarctation, pseudoaneurysm, aortic perforation, etc.).

Follow-up Visits and Length of Follow-up 10 years


ODE Lead-Cont f/u of premarket cohorts w/stent fra Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 03/25/2017 03/24/2017 On Time
two year report 03/25/2018    
three year report 03/25/2019    
four year report 03/24/2020    
five year report 03/24/2021    


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

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