Trial Outcomes & Findings for An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis (NCT NCT00929383)

NCT ID: NCT00929383

Last Updated: 2014-06-17

Results Overview

The number of Wingspan Stents successfully deployed across the target lesion.

• Recruitment status: COMPLETED
• Target enrollment: 82 participants
• Primary outcome timeframe: Peri-procedural
• Results posted on: 2014-06-17

Participant Flow

Patients eligible were diagnosed with symptomatic Intracranial Atheroslcerotic disease and scheduled to be treated with a Wingspan Stent in 6 centers in France and 9 centers in Germany. The first patient was enrolled on 11 March 2009 and last patient on 30 April 2012.

This was an open label registry (observational study). All patients scheduled for treatment with a Wingspan Stent meeting inclusion/exclusion criteria were eligible for participation.

Participant milestones

Measure	Wingspan Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
Overall Study STARTED	82
Overall Study COMPLETED	67
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis

Baseline characteristics by cohort

Measure	Patients Treated With a Wingspan Stent n=82 Participants Prospective, single arm, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
Age, Continuous	64.23 years STANDARD_DEVIATION 10.78 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: Peri-procedural

Population: (ITT) Intent-to-treat

The number of Wingspan Stents successfully deployed across the target lesion.

Outcome measures

Measure	Patients Treated With a Wingspan Stent n=82 Participants Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion)	78 patients w stent implanted

PRIMARY outcome

Timeframe: 30 days

Population: (ITT) Intent-to-treat

Any stroke or neurological death at </= 30 days will be included in the cumulative morbidity and mortality rate.

There was a 14.6% rate of cumulative morbidity and mortality at 30 days comprised of 12 events/82 patients.

Outcome measures

Measure	Patients Treated With a Wingspan Stent n=82 Participants Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death)	12 participants

PRIMARY outcome

Timeframe: 12 Months

Population: (ITT) Intent-to-treat

The rate of recurrent ischemic stroke from 31 days to 12 months post procedure was 1.3% or 1 event per 77 patients analyzed.

Outcome measures

Measure	Patients Treated With a Wingspan Stent n=77 Participants Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
Rate of Recurrent Ischemic Stroke in the Target Territory	1 participants

SECONDARY outcome

Timeframe: 12 months

Population: (ITT) Intent-to-treat

The cumulative stroke rate at 12 months (any stroke or neurological death </= 30 days or any ischemic stroke in territory >/= 31 days is 15.9% or 13 events per 82 patients

Outcome measures

Measure	Patients Treated With a Wingspan Stent n=82 Participants Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
Cumulative Stroke Rate at 12 Months	13 participants

SECONDARY outcome

Timeframe: 12 Months

Population: There were only N=77 patients available for analysis of restenosis at 12 months. This differs from the original N=82 ITT population in that denominator is based on the number of subjects available at 30 day follow up. Five subjects who exited the study at discharge were excluded from the analysis (no stent implanted (4), death (1)).

The rate of restenosis at 12 months was defined as the degree of residual stenosis greater than 50% as determined by the study sites using the WASID method. There was a 10.4% rate of restenosis >50% or 8 patients out of 77 analyzed. The differences in this analysis population N=77 vs. ITT N= 82 populations results from exclusion of N=4 patients with no stent implanted and N=1 patient who died prior to any follow up measures of restenosis.

The WASID method is a standardized protocol for measuring intracranial arterial stenosis.

[1-(Dstenosis/Dnormal)] x100=% stenosis (where D=vessel diameter)

Outcome measures

Measure	Patients Treated With a Wingspan Stent n=77 Participants Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
Rate of Restenosis	8 participants

Adverse Events

Wingspan

Serious events: 29 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Wingspan n=82 participants at risk Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
Cardiac disorders Cardiac failure	1.2% 1/82 • Number of events 1 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
Cardiac disorders Myocardial infarction	2.4% 2/82 • Number of events 2 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
General disorders Catheter site hematoma	1.2% 1/82 • Number of events 1 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
General disorders Multi-organ failure	1.2% 1/82 • Number of events 1 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
Injury, poisoning and procedural complications In-stent arterial restenosis	4.9% 4/82 • Number of events 4 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
Nervous system disorders Cerebral haemorrhage	1.2% 1/82 • Number of events 1 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
Nervous system disorders Cerebrovascular accident	14.6% 12/82 • Number of events 12 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
Nervous system disorders Convulsion	1.2% 1/82 • Number of events 1 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
Nervous system disorders Hydrocephalus	1.2% 1/82 • Number of events 1 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
Nervous system disorders Neurological decompensation	1.2% 1/82 • Number of events 1 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
Nervous system disorders Subarachnoid haemorrhage	1.2% 1/82 • Number of events 1 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
Nervous system disorders Transient ischaemic attack	6.1% 5/82 • Number of events 6 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
Renal and urinary disorders Renal cancer	1.2% 1/82 • Number of events 1 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
Renal and urinary disorders Urethral cancer	1.2% 1/82 • Number of events 1 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
Vascular disorders Artery dissection	1.2% 1/82 • Number of events 1 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
Vascular disorders Thrombosis in device	1.2% 1/82 • Number of events 1 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.

Other adverse events

Measure	Wingspan n=82 participants at risk Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
Eye disorders Conjunctivitis	1.2% 1/82 • Number of events 1 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
Nervous system disorders Cerebrovascular accident	1.2% 1/82 • Number of events 1 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
Nervous system disorders Headache	1.2% 1/82 • Number of events 1 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
Nervous system disorders Syncope	1.2% 1/82 • Number of events 1 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
Vascular disorders Artery dissection	1.2% 1/82 • Number of events 1 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
Vascular disorders Hypertensive crisis	1.2% 1/82 • Number of events 1 • Adverse event data was collected from the procedure until last follow up visit (12 months). Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.

Additional Information

David Hess, Manager Clinical Affairs

Stryker Neurovascular

Phone: 1-510-413-2642

Email: david.hess@stryker.com

Results disclosure agreements

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