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Feasibility study to assess safety of treating patients with self expanding stent in intracranial arteries.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Atherosclerosis Arm | Experimental | Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System |
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| Group 2: Aneurysm Arm | Active Comparator | Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cordis Neurovascular ENTERPRISE Self Expanding Stent System | Device | Implantation of the device ENTERPRISE used to treat symptomatic stenosis in intracranial arteries. |
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| Measure | Description | Time Frame |
|---|---|---|
| Technical Feasibility- Successful Stent/Coil Placement (Post Procedure) | Successful placement of the product assessed immediately post procedure | post procedure |
| Technical Feasibility- Percent Occlusion (Post Procedure) | Occlusion evaluated immediately post procedure | post procedure |
| Technical Feasibility- Percent Occlusion (6 Mo Post Procedure) | 6 Months post | 6 mo |
| Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure) | Successful stent/coil placement assessed at 6 mo post | 6 mo |
| Technical Feasibility- Percent Stenosis (6 mo Post Procedure) | Percent Stenosis assessed 6 mo Post Procedure from pre-procedure | 6 mo |
| Technical Feasibility- Percent Stenosis (Post Procedure) | Percent Stenosis assessed immediately post procedure from pre procedure | Post Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Contact site for specific information
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro Lylyk, MD | ENERI-CLINICA ADVENTISTA BELGRANO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eneri-Clinica Adventista Belgrano | Belgrano | Argentina |
This is a device study, there was no wash out or run-in phase for transition.
Patients were recruited at 1 hospital in Argentina in 2006 and 2007 and treated with Codman Neurovascular Self-Expanding Stent System.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aneurysm Arm | Intracranial wide-necked aneurysms |
| FG001 | Atherosclerosis Arm | Symptomatic stenosis in intracranial arteries |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Cordis Neurovascular ENTERPRISE Self Expanding Stent System | Device | Implantation of the device ENTERPRISE to treat wide-necked aneurysms |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aneurysm Arm | Intracranial wide-necked aneurysms |
| BG001 | Atherosclerosis Arm | Symptomatic stenosis in intracranial arteries |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Technical Feasibility- Successful Stent/Coil Placement (Post Procedure) | Successful placement of the product assessed immediately post procedure | Posted | Number | percentage of stable placement | post procedure |
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| 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. | 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. | Posted | Number | Number of adverse events | 6 months |
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| Primary | Technical Feasibility- Percent Occlusion (Post Procedure) | Occlusion evaluated immediately post procedure | Group 1 - Atherosclerosis Arm not analyzed for occlusion. Occlusion only relevant in Aneurysm treatment. | Posted | Mean | Full Range | percent occlusion | post procedure |
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| Primary | Technical Feasibility- Percent Occlusion (6 Mo Post Procedure) | 6 Months post | Group 1 - Atherosclerosis Arm not analyzed for occlusion. Occlusion only relevant in Aneurysm treatment. | Posted | Mean | Full Range | percent occlusion | 6 mo |
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| Primary | Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure) | Successful stent/coil placement assessed at 6 mo post | Posted | Number | Percentage of stable stent/coil placemen | 6 mo |
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| Primary | Technical Feasibility- Percent Stenosis (6 mo Post Procedure) | Percent Stenosis assessed 6 mo Post Procedure from pre-procedure | Group 2 - Aneurysm Arm not analyzed for stenosis. Stenosis only relevant in Atherosclerosis treatment. | Posted | Mean | Standard Deviation | Percentage change from PreProcedure | 6 mo |
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| Primary | Technical Feasibility- Percent Stenosis (Post Procedure) | Percent Stenosis assessed immediately post procedure from pre procedure | Group 2 - Aneurysm Arm not analyzed for stenosis. Stenosis only relevant in Atherosclerosis treatment. | Posted | Mean | Standard Deviation | Percentage Change from PreProcedure | Post Procedure |
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From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment.
For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Atherosclerosis Arm | This is the events from the Atherosclerosis Arm | 3 | 10 | 8 | 10 | ||
| EG001 | Group 2: Aneurysm Arm | This is the events from the Aneurysm Arm | 3 | 10 | 9 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
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| Lung Tumor | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Ischemic Stroke | Nervous system disorders | Systematic Assessment |
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| Hip Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Stroke/CVA: Ischemic stroke | Nervous system disorders | Systematic Assessment |
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| Other: Primitive Left Carotid Ligation | Vascular disorders | Systematic Assessment |
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| Neurological Deficit: left hemianes-thesia and cranial nerve X1 palsy | Vascular disorders | Systematic Assessment |
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| Other: Gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Hematoma | Nervous system disorders | Systematic Assessment |
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| Hypo-Hypertension | Blood and lymphatic system disorders | Systematic Assessment |
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| Ischemia | Nervous system disorders | Systematic Assessment |
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| Myocardial Infarction | Nervous system disorders | Systematic Assessment |
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| Stroke/CVA | Nervous system disorders | Systematic Assessment |
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| Other: Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Other: Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Other: Confusion | Nervous system disorders | Systematic Assessment |
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| Other: Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Other: Elevated Blood Glucose | Blood and lymphatic system disorders | Systematic Assessment |
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| Other: Hip Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Other: Insomnia | General disorders | Systematic Assessment |
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| Other: Lung Tumor | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Other: Nausea | General disorders | Systematic Assessment |
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| Other: Postural Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Other: Psychomotor excitation | Nervous system disorders | Systematic Assessment |
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| Other: Tiredness | General disorders | Systematic Assessment |
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| Other: Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Hematoma | Vascular disorders | Systematic Assessment |
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| Hemorrhage | Blood and lymphatic system disorders | Systematic Assessment |
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| Neurological Deficit | Vascular disorders | Systematic Assessment |
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| Seizures | Vascular disorders | Systematic Assessment |
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| Stent Migration/Embolization | Vascular disorders | Systematic Assessment |
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| Other: Cervical, Dorsal, and/or Lumbar Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Other: Eye Pain Sensation | Eye disorders | Systematic Assessment |
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| Other: Gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Other: Photophoby | Eye disorders | Systematic Assessment |
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| Other: Polyuria | Renal and urinary disorders | Systematic Assessment |
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| Other: Primitive Left Carotid Ligation | Vascular disorders | Systematic Assessment |
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| Other: Vomiting | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Thomas Megerian, MD | Codman & Shurtleff | 508.828.8274 | jmegerian1@its.jnj.com |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| >=65 years |
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| Male |
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