Intracranial Atherosclerosis
Conditions
Keywords
Intracranial Atherosclerosis, Stenosis, ICAD, atherosclerotic lesions, stenting
Brief summary
The IRISS study is designed to collect clinical and angiographic outcomes data when stenting intracranial atherosclerotic lesions using the Wingspan™ Stent System with Gateway™ PTA Balloon Catheter in routine clinical practice.
Detailed description
The Wingspan™ Stent System and Gateway™ PTA Balloon Catheter have CE mark and are commonly used in Europe. All the data collected in this registry will be from patients treated according to the physician's choice, per instructions for use, per approved indications and per local standard of care. The results from this registry will provide an understanding of the use and outcomes associated with the Wingspan™ Stent in a real world setting.
Interventions
DEVICEWingspan Stent System with Gateway PTA Balloon Catheter
The Wingspan Stent System is used in conjunction with Gateway PTA Balloon Catheter to improve cerebral artery lumen diameter in patients with intracranial atherosclerotic disease. The Gateway Balloon Catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries prior to stenting the artery for the purpose of improving intracranial perfusion.
Sponsors
Stryker Neurovascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
41 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic stenosis of one of those intracranial arteries: Internal carotid artery (ICA ), M1 segment of the MCA, V4 segment of vertebral artery, basilar artery * A Modified Rankin Score of ≤ 3 * A target vessel diameter between 2mm and ≤ 4.5mm * Length of the target lesion of ≤ 14 mm * Patient older than 40 years old
Exclusion criteria
* Patient previously stented at the target lesion * Intracranial stenosis related to disease such as: arterial dissection, Moya Moya disease, vasculitis, radiation induced vasculopathy or fibromuscular dysplasia * Complete occlusion of the artery on the imaging assessment * Contraindications to antithrombotic and/or anticoagulant therapies * Women who are pregnant or breast-feeding * Patient not likely to be available for follow-up * Patient protected by the law (safeguard of justice, supervision or trusteeship)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion) | Peri-procedural | The number of Wingspan Stents successfully deployed across the target lesion. |
| Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death) | 30 days | 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. |
| Rate of Recurrent Ischemic Stroke in the Target Territory | 12 Months | The rate of recurrent ischemic stroke from 31 days to 12 months post procedure was 1.3% or 1 event per 77 patients analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Stroke Rate at 12 Months | 12 months | 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 |
| Rate of Restenosis | 12 Months | 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) |
Countries
France, Germany
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Patients Treated With a Wingspan Stent 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 | 82 |
| Total | 82 |
Baseline characteristics
| Characteristic | Patients Treated With a Wingspan Stent |
|---|---|
| Age, Continuous | 64.23 years STANDARD_DEVIATION 10.78 |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 82 |
| serious Total, serious adverse events | 29 / 82 |
Outcome results
Primary
Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death)
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.
Time frame: 30 days
Population: (ITT) Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Treated With a Wingspan Stent | Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death) | 12 participants |
Primary
Rate of Recurrent Ischemic Stroke in the Target Territory
The rate of recurrent ischemic stroke from 31 days to 12 months post procedure was 1.3% or 1 event per 77 patients analyzed.
Time frame: 12 Months
Population: (ITT) Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Treated With a Wingspan Stent | Rate of Recurrent Ischemic Stroke in the Target Territory | 1 participants |
Primary
Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion)
The number of Wingspan Stents successfully deployed across the target lesion.
Time frame: Peri-procedural
Population: (ITT) Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Treated With a Wingspan Stent | 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 |
Secondary
Cumulative Stroke Rate at 12 Months
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
Time frame: 12 months
Population: (ITT) Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Treated With a Wingspan Stent | Cumulative Stroke Rate at 12 Months | 13 participants |
Secondary
Rate of Restenosis
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)
Time frame: 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)).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Treated With a Wingspan Stent | Rate of Restenosis | 8 participants |