Aneurysm, Atherosclerosis
Conditions
Keywords
Atherosclerosis,Wide Neck Aneurysm
Brief summary
Feasibility study to assess safety of treating patients with self expanding stent in intracranial arteries.
Detailed description
Feasibility study to assess safety of treating patients with self expanding stent in intracranial arteries. Patients will be followed for 6 months with assessments related to technical feasibility and adverse events.
Interventions
DEVICECordis Neurovascular ENTERPRISE Self Expanding Stent System
Implantation of the device ENTERPRISE used to treat symptomatic stenosis in intracranial arteries.
Sponsors
Codman & Shurtleff
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Contact site for specific information Inclusion Criteria: * Subject meet specific criteria for treatment * Subject must be willing to return to site for 30 day and 6 month follow up evaluations
Exclusion criteria
* Stenting, angioplasty or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to expected enrollment date * Previously implanted carotid stent associated with the symptomatic distribution within the past 12 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Feasibility- Percent Occlusion (6 Mo Post Procedure) | 6 mo | 6 Months post |
| Technical Feasibility- Successful Stent/Coil Placement (Post Procedure) | post procedure | Successful placement of the product assessed immediately post procedure |
| Technical Feasibility- Percent Occlusion (Post Procedure) | post procedure | Occlusion evaluated immediately post procedure |
| Technical Feasibility- Percent Stenosis (Post Procedure) | Post Procedure | Percent Stenosis assessed immediately post procedure from pre procedure |
| Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure) | 6 mo | Successful stent/coil placement assessed at 6 mo post |
| Technical Feasibility- Percent Stenosis (6 mo Post Procedure) | 6 mo | Percent Stenosis assessed 6 mo Post Procedure from pre-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately. | 6 months | An adverse event was defined as any untoward medical occurrence in a subject. |
Countries
Argentina
Participant flow
Recruitment details
Patients were recruited at 1 hospital in Argentina in 2006 and 2007 and treated with Codman Neurovascular Self-Expanding Stent System.
Pre-assignment details
This is a device study, there was no wash out or run-in phase for transition.
Participants by arm
| Arm | Count |
|---|---|
| Aneurysm Arm Intracranial wide-necked aneurysms | 10 |
| Atherosclerosis Arm Symptomatic stenosis in intracranial arteries | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | Atherosclerosis Arm | Aneurysm Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 10 Participants | 19 Participants |
| Age, Continuous | 63.7 years STANDARD_DEVIATION 9 | 64 years STANDARD_DEVIATION 9 | 63.85 years STANDARD_DEVIATION 9 |
| Region of Enrollment Argentina | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 10 | 9 / 10 |
| serious Total, serious adverse events | 3 / 10 | 3 / 10 |
Outcome results
Primary
Technical Feasibility- Percent Occlusion (6 Mo Post Procedure)
6 Months post
Time frame: 6 mo
Population: Group 1 - Atherosclerosis Arm not analyzed for occlusion. Occlusion only relevant in Aneurysm treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 2 | Technical Feasibility- Percent Occlusion (6 Mo Post Procedure) | 88.8 percent occlusion |
Primary
Technical Feasibility- Percent Occlusion (Post Procedure)
Occlusion evaluated immediately post procedure
Time frame: post procedure
Population: Group 1 - Atherosclerosis Arm not analyzed for occlusion. Occlusion only relevant in Aneurysm treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 2 | Technical Feasibility- Percent Occlusion (Post Procedure) | 86.8 percent occlusion |
Primary
Technical Feasibility- Percent Stenosis (6 mo Post Procedure)
Percent Stenosis assessed 6 mo Post Procedure from pre-procedure
Time frame: 6 mo
Population: Group 2 - Aneurysm Arm not analyzed for stenosis. Stenosis only relevant in Atherosclerosis treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Technical Feasibility- Percent Stenosis (6 mo Post Procedure) | -47.3 Percentage change from PreProcedure | Standard Deviation 21.2 |
Primary
Technical Feasibility- Percent Stenosis (Post Procedure)
Percent Stenosis assessed immediately post procedure from pre procedure
Time frame: Post Procedure
Population: Group 2 - Aneurysm Arm not analyzed for stenosis. Stenosis only relevant in Atherosclerosis treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Technical Feasibility- Percent Stenosis (Post Procedure) | -38.5 Percentage Change from PreProcedure | Standard Deviation 18.3 |
Primary
Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure)
Successful stent/coil placement assessed at 6 mo post
Time frame: 6 mo
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure) | 100 Percentage of stable stent/coil placemen |
| Group 2 | Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure) | 100 Percentage of stable stent/coil placemen |
Primary
Technical Feasibility- Successful Stent/Coil Placement (Post Procedure)
Successful placement of the product assessed immediately post procedure
Time frame: post procedure
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group 1 | Technical Feasibility- Successful Stent/Coil Placement (Post Procedure) | 100 percentage of stable placement | 47.3 |
| Group 2 | Technical Feasibility- Successful Stent/Coil Placement (Post Procedure) | 90 percentage of stable placement | 14.7 |
Secondary
The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately.
An adverse event was defined as any untoward medical occurrence in a subject.
Time frame: 6 months
Population: Group 1 and Group 2 were analyzed separately. In group 1 Atherosclerosis, 25 unique adverse events were reported in 8 of the 10 eligible subjects. In group 2 aneurysm, 28 unique adverse events were reported in 9 of the 10 eligible subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately. | 25 Number of adverse events |
| Group 2 | The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately. | 28 Number of adverse events |