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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

Rates of Stroke and Death


 
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General
Study Status Completed
522 Number / Requirement Number PS120110 / PSS001
Date Current Plan Accepted 06/17/2013
Study Name Rates of Stroke and Death
Root Document Number H050001 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Primary Objective

To evaluate the rate of stroke and death within 72 hours in patients treated with the Wingspan Stent System in accordance with the Indications for Use.

• Ischemic stroke is defined as a neurological deficit that is thought to have an ischemic cause and is detectable on examination at least 24 hours after onset of symptoms.

• Hemorrhagic stroke is defined as a symptomatic intracerebral, subarachnoid, or primary intraventricular hemorrhage. To be considered a hemorrhagic stroke, the patient must experience new symptoms (e.g., new severe headache) lasting for at least 24 hours (symptoms do not need to be associated with a new neurological deficit).

• Stroke type (ischemic or hemorrhagic) must be confirmed by imaging.



Secondary Objectives

To determine the following for any stented patient experiencing a stroke within 72 hours following the procedure.

• Required interventions

• Type of stroke (ischemic or hemorrhagic)

• Timing of event resolution

To determine the cause of death for any stented patient that dies within

72 hours following the procedure.

To determine if there is a relationship between the post procedure stroke or death rate within 72 hours and baseline factors including but not limited to the following:

• Level of operator experience at the time of treating their first study patient

• Baseline characteristics (demographics and clinical characteristics)

• Procedural characteristics

• Post procedure patient management

• Operator specialty



Study Population Description

All patients who have a Wingspan stent procedure attempted will be considered enrolled in the study.
Sample Size Approximately 389 subjects will be required to obtain 350 subjects eligible for the primary analysis at a maximum of 50 sites (US or International) is planned. Enrollment rate is expected to be between 75 and 250 patients per year. Minimum number of US or International sites: 30 sites. Minimum number of US sites: 25 sites.
Data Collection Primary Endpoint

The primary endpoint is the rate of stroke or death within 72 hours of

the procedure.

Secondary endpoints include the following:

• Hemorrhagic stroke within 72 hours post procedure

• Ischemic stroke within 72 hours post procedure

• Neurological death within 72 hours post procedure

• Stroke recovery at 90 days post procedure

• Stroke in the territory of the stented artery within 72 hours post procedure



Follow-up Visits and Length of Follow-up 72 hours Post Procedure

The following assessments will be performed on all patients with a stent at 72 hours (± 8 hours) post procedure or at the time of discharge, whichever comes first:

• Neurological exam

• Modified Rankin Scale

• Medications

All medications administered from procedure end to 72 hours or discharge will be recorded. Specific medications for subsequent management of risk factors will be at the discretion of the treating physician and will be recorded.

• Adverse events



The subject may be discharged from the hospital when clinically stable, at the Investigator’s discretion. If a patient who received a stent is discharged before 64 hours post procedure, the study site must immediately notify the Independent Stroke Neurologist (ISN) by email of the need to contact the patient for additional telephone follow-up on Day 4 (see 5.4.2). Details of the patient’s discharge assessment including neurological exam, modified Rankin Scale and medications must also be provided to the ISN.



The designated staff at the clinical site will review the study requirements with the subject to maximize compliance with the follow- up schedule and any prescribed medications. It is imperative that

patients understand the need to complete the post procedure telephone contact if discharged early.



Patients who are enrolled but do not receive a stent will not be required to have study follow up assessments.



Day 4 Post Procedure

Patients who receive a stent and are discharged prior to 64 hours post procedure will be contacted by the ISN on Day 4 (96 ± 24 hours post procedure) by telephone to ensure that any potential strokes that occurred post discharge are systematically identified and documented. The following assessments will be conducted.

• Stroke symptom assessment

• Modified Rankin Scale

• Medications

All medications the patient has taken since discharge will be assessed and recorded.



If the patient has experienced any new or worsening symptoms or there is a worsening of the modified Rankin score since discharge, the study site will be notified by the ISN and the patient will be instructed to contact the study site immediately for follow-up. If the study site determines that the patient experienced a stroke within 72 hours of the procedure, the patient must be followed for an additional 90 days per Table 2 below.



If a patient or alternative contact are unable be contacted on Day 4, the ISN will make two additional attempts to contact the patient and/or alternate contact up to 90 days. Attempts to contact the patient should be documented. The completed Telephone Assessment Form and/or documentation of attempts to contact the patient will be provided to the study site. The ISN or the study site will perform entry of the data into the CRF and the site will retain documentation with the study files.



Post Stroke Follow-Up

Patients who receive a stent and have a stroke within 72 hours post procedure will be followed for 90 days to assess functional outcomes per Table 2 below. If a patient has had a stroke within 72 hours and was treated at an outside facility, every attempt should be made to obtain medical records and information on the etiology and treatment of the stroke. Post stroke follow-up assessments are not required as part of the study protocol for patients who have a stroke within 72 hours but did

not receive a stent.



Enrollment Plan and Follow-up Measures

While study withdrawal is discouraged, subjects may withdraw from the study at any time, with or without reason and without prejudice to further treatment. Withdrawn subjects will not undergo any additional follow-up, nor will they be replaced.







Interim or Final Data Summary
Actual Number of Patients Enrolled 198 patients with 152 patients in the primary analysis group (device used in accordance with the FDA-approved indications for use and labeling) and 46 patients used device outside of the FDA-approved indications for use and patient population.





Actual Number of Sites Enrolled A total of 37 US sites enrolled in the WEAVE study and out of which 24 US sites enrolled any patients.





Patient Followup Rate 100% at 72 hours follow-up
Final Safety Findings 4. Final findings

• In the “primary analysis” cohort, 97.4% of subjects (148/152) had no stroke or death reported in the first 72 hours, whereas 1.3% (2/152) had reported death within 72 hours and 1.3% (2/152) experienced stroke without death within 72 hours.

• The observed stroke or death rate for the cohort that used device outside of the FDA-approved indications for use and patient population was 23.9% (11/46, 95% CI: 12.6% - 38.8%), which is significantly higher than the rate found in the “primary analysis” cohort.

• The safety related adverse events (AEs) and serious adverse events (SAEs) other than stroke or death in the “primary analysis” cohort did not exceed expectation.



Study Strengths and Weaknesses

• Short study time window (72 hrs) leads to adequate follow-up rate.

• Objective primary endpoints (death or stroke) lead to less bias in the assessment of device performance and safety.

• The study assessed real-world device performance in a broad patient population.

Recommendations for Labeling Changes The final safety and effectiveness findings reported in the final report of the WEAVE study should be added to the labeling. The revisions or addendum to the labeling generated using WEAVE data should include the primary and secondary endpoints of both the “primary analysis” cohort and the cohort of patients treated outside the FDA- approved indications for use and labeling. FDA is requesting the manufacturer add a “box warning” about the safety and performance of the device when used outside of the FDA-approved indications for use and patient population.







Rates of Stroke and Death Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/17/2013 12/13/2013 On Time
one year report 06/17/2014 06/16/2014 On Time
18 month report 12/17/2014 12/18/2014 Overdue/Received
two year report 06/17/2015 06/23/2015 On Time
three year report 06/17/2016 06/17/2016 On Time
unschedule report 08/10/2016 08/10/2016 On Time
unschedule report for IRB 12/19/2016 12/19/2016 On Time
unscheduled report 06/05/2017 06/05/2017 On Time
four year report 06/17/2017 06/15/2017 On Time
unscheduled report 11/09/2017 11/09/2017 On Time
unscheduled report 12/07/2017 12/07/2017 On Time
unscheduled Final Report 06/16/2018 04/26/2018 Overdue/Received


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov
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