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| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS120110 / PSS001 |
| Date Original Plan Accepted |
06/17/2013
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| Date Current Plan Accepted |
06/17/2013
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| Study Name |
Rates of Stroke and Death
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| Device Name |
Wingspan stent system and gateway pta balloon catheter
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| Root Document Number |
H050001
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
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
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| Study Population |
All patients who have a Wingspan stent procedure attempted will be considered enrolled in the study.
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| 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.
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| Key Study Endpoints |
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
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| 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.
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| 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.
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| 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.
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| Patient Followup Rate |
100% at 72 hours follow-up
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| 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.
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| 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.
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| 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.
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