Trial Outcomes & Findings for Post Market Surveillance Study of the Wingspan Stent System (NCT NCT02034058)

NCT ID: NCT02034058

Last Updated: 2019-12-02

Results Overview

The primary endpoint in this study is the rate of stroke (ischemic or hemorrhagic) or death within 72 hours of the procedure. Ischemic stroke was 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 was defined as a symptomatic intracerebral, subarachnoid, or primary intraventricular hemorrhage. The type of stroke was confirmed by imaging.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 152 participants
• Primary outcome timeframe: within 72 hours of the procedure
• Results posted on: 2019-12-02

Participant Flow

Participant milestones

Measure	Stenting Prospective, single-arm, consecutive enrollment, post market surveillance study of patients treated with the Wingspan Stent System, according to the Indications for Use.
Overall Study STARTED	152
Overall Study COMPLETED	149
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Stenting Prospective, single-arm, consecutive enrollment, post market surveillance study of patients treated with the Wingspan Stent System, according to the Indications for Use.
Overall Study Death	3

Baseline Characteristics

Post Market Surveillance Study of the Wingspan Stent System

Baseline characteristics by cohort

Measure	Stenting n=152 Participants Prospective, single-arm, consecutive enrollment, post market surveillance study of patients who have a Wingspan stent procedure attempted.
Age, Continuous	61.89 years STANDARD_DEVIATION 10.52 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants
Sex: Female, Male Male	81 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	101 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · African American or Black	30 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	4 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic or Latino	12 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Multiracial	5 Participants n=5 Participants
Baseline modified Rankin Scale 0	20 Participants n=5 Participants
Baseline modified Rankin Scale 1	37 Participants n=5 Participants
Baseline modified Rankin Scale 2	52 Participants n=5 Participants
Baseline modified Rankin Scale 3	43 Participants n=5 Participants
Baseline modified Rankin Scale 4	0 Participants n=5 Participants
Baseline modified Rankin Scale 5	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: within 72 hours of the procedure

The primary endpoint in this study is the rate of stroke (ischemic or hemorrhagic) or death within 72 hours of the procedure. Ischemic stroke was 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 was defined as a symptomatic intracerebral, subarachnoid, or primary intraventricular hemorrhage. The type of stroke was confirmed by imaging.

Outcome measures

Measure	Stenting n=152 Participants Prospective, single-arm, consecutive enrollment, post market surveillance study of patients treated with the Wingspan Stent System, according to the Indications for Use.
Rate of Stroke or Death Among Participants	4 Participants

SECONDARY outcome

Timeframe: within 72 hours post procedure

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

Outcome measures

Measure	Stenting n=152 Participants Prospective, single-arm, consecutive enrollment, post market surveillance study of patients treated with the Wingspan Stent System, according to the Indications for Use.
Rate of Ischemic Stroke Among Participants	1 Participants

SECONDARY outcome

Timeframe: within 72 hours post procedure

A diagnosis of death by neurological criteria

Outcome measures

Measure	Stenting n=152 Participants Prospective, single-arm, consecutive enrollment, post market surveillance study of patients treated with the Wingspan Stent System, according to the Indications for Use.
Rate of Neurological Death Among Participants	2 Participants

SECONDARY outcome

Timeframe: at 90 days post procedure

Stroke recovery at 90 days post procedure is defined by return to baseline mRS at Day 90.

Outcome measures

Measure	Stenting n=152 Participants Prospective, single-arm, consecutive enrollment, post market surveillance study of patients treated with the Wingspan Stent System, according to the Indications for Use.
Rate of Stroke Recovery Among Participants	0 Participants

SECONDARY outcome

Timeframe: within 72 hours post procedure

Stroke in the vascular territory of the stented artery

Outcome measures

Measure	Stenting n=152 Participants Prospective, single-arm, consecutive enrollment, post market surveillance study of patients treated with the Wingspan Stent System, according to the Indications for Use.
Rate of Stroke in the Territory of the Stented Artery Among Participants	4 Participants

Adverse Events

Stenting

Serious events: 9 serious events

Other events: 12 other events

Deaths: 3 deaths

Serious adverse events

Measure	Stenting n=152 participants at risk Prospective, single-arm, consecutive enrollment, post market surveillance study of patients treated with the Wingspan Stent System, according to the Indications for Use.
Nervous system disorders Haemorrhagic stroke	2.0% 3/152 • Number of events 3 • Serious and Other Adverse Events were monitored/assessed for up to 72 hours post-procedure. All-Cause Mortality was monitored/assessed through 90 days post procedure. Only neurological AEs, bleeding/hemorrhagic AEs (including non-neurological events), groin puncture AEs and AEs that resulted in death experienced by the study subject after enrollment were collected.
Injury, poisoning and procedural complications Craniocerebral injury	0.66% 1/152 • Number of events 1 • Serious and Other Adverse Events were monitored/assessed for up to 72 hours post-procedure. All-Cause Mortality was monitored/assessed through 90 days post procedure. Only neurological AEs, bleeding/hemorrhagic AEs (including non-neurological events), groin puncture AEs and AEs that resulted in death experienced by the study subject after enrollment were collected.
Nervous system disorders Ischaemic stroke	0.66% 1/152 • Number of events 1 • Serious and Other Adverse Events were monitored/assessed for up to 72 hours post-procedure. All-Cause Mortality was monitored/assessed through 90 days post procedure. Only neurological AEs, bleeding/hemorrhagic AEs (including non-neurological events), groin puncture AEs and AEs that resulted in death experienced by the study subject after enrollment were collected.
Nervous system disorders Neurological decompensation	0.66% 1/152 • Number of events 1 • Serious and Other Adverse Events were monitored/assessed for up to 72 hours post-procedure. All-Cause Mortality was monitored/assessed through 90 days post procedure. Only neurological AEs, bleeding/hemorrhagic AEs (including non-neurological events), groin puncture AEs and AEs that resulted in death experienced by the study subject after enrollment were collected.
Nervous system disorders Subarachnoid haemorrhage	0.66% 1/152 • Number of events 1 • Serious and Other Adverse Events were monitored/assessed for up to 72 hours post-procedure. All-Cause Mortality was monitored/assessed through 90 days post procedure. Only neurological AEs, bleeding/hemorrhagic AEs (including non-neurological events), groin puncture AEs and AEs that resulted in death experienced by the study subject after enrollment were collected.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.66% 1/152 • Number of events 1 • Serious and Other Adverse Events were monitored/assessed for up to 72 hours post-procedure. All-Cause Mortality was monitored/assessed through 90 days post procedure. Only neurological AEs, bleeding/hemorrhagic AEs (including non-neurological events), groin puncture AEs and AEs that resulted in death experienced by the study subject after enrollment were collected.
Vascular disorders Hypertension	0.66% 1/152 • Number of events 1 • Serious and Other Adverse Events were monitored/assessed for up to 72 hours post-procedure. All-Cause Mortality was monitored/assessed through 90 days post procedure. Only neurological AEs, bleeding/hemorrhagic AEs (including non-neurological events), groin puncture AEs and AEs that resulted in death experienced by the study subject after enrollment were collected.

Other adverse events

Measure	Stenting n=152 participants at risk Prospective, single-arm, consecutive enrollment, post market surveillance study of patients treated with the Wingspan Stent System, according to the Indications for Use.
General disorders Administration site pain	1.3% 2/152 • Number of events 2 • Serious and Other Adverse Events were monitored/assessed for up to 72 hours post-procedure. All-Cause Mortality was monitored/assessed through 90 days post procedure. Only neurological AEs, bleeding/hemorrhagic AEs (including non-neurological events), groin puncture AEs and AEs that resulted in death experienced by the study subject after enrollment were collected.
General disorders Application site haematoma	2.0% 3/152 • Number of events 3 • Serious and Other Adverse Events were monitored/assessed for up to 72 hours post-procedure. All-Cause Mortality was monitored/assessed through 90 days post procedure. Only neurological AEs, bleeding/hemorrhagic AEs (including non-neurological events), groin puncture AEs and AEs that resulted in death experienced by the study subject after enrollment were collected.
Nervous system disorders Haemorrhage intracranial	0.66% 1/152 • Number of events 1 • Serious and Other Adverse Events were monitored/assessed for up to 72 hours post-procedure. All-Cause Mortality was monitored/assessed through 90 days post procedure. Only neurological AEs, bleeding/hemorrhagic AEs (including non-neurological events), groin puncture AEs and AEs that resulted in death experienced by the study subject after enrollment were collected.
Nervous system disorders Headache	2.0% 3/152 • Number of events 3 • Serious and Other Adverse Events were monitored/assessed for up to 72 hours post-procedure. All-Cause Mortality was monitored/assessed through 90 days post procedure. Only neurological AEs, bleeding/hemorrhagic AEs (including non-neurological events), groin puncture AEs and AEs that resulted in death experienced by the study subject after enrollment were collected.
Nervous system disorders Muscular weakness	0.66% 1/152 • Number of events 1 • Serious and Other Adverse Events were monitored/assessed for up to 72 hours post-procedure. All-Cause Mortality was monitored/assessed through 90 days post procedure. Only neurological AEs, bleeding/hemorrhagic AEs (including non-neurological events), groin puncture AEs and AEs that resulted in death experienced by the study subject after enrollment were collected.
Nervous system disorders Neurological symptom	1.3% 2/152 • Number of events 2 • Serious and Other Adverse Events were monitored/assessed for up to 72 hours post-procedure. All-Cause Mortality was monitored/assessed through 90 days post procedure. Only neurological AEs, bleeding/hemorrhagic AEs (including non-neurological events), groin puncture AEs and AEs that resulted in death experienced by the study subject after enrollment were collected.
Nervous system disorders Transient ischaemic attack	0.66% 1/152 • Number of events 1 • Serious and Other Adverse Events were monitored/assessed for up to 72 hours post-procedure. All-Cause Mortality was monitored/assessed through 90 days post procedure. Only neurological AEs, bleeding/hemorrhagic AEs (including non-neurological events), groin puncture AEs and AEs that resulted in death experienced by the study subject after enrollment were collected.

Additional Information

Alice Lin, Clinical Program Manager

Stryker Neurovascular

Phone: 510 413 2673

Email: alice.lin@stryker.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place