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The purposes of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device | Experimental | Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device | Device | Carotid artery stenting with distal embolic protection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure. | Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation. | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Ansel, MD | MidWest Cardiology Research Foundation | Principal Investigator |
| Robert Safian, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University Hospital | Stony Brook | New York | United States | |||
| Wellmont Medical Center |
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| Label | URL |
|---|---|
| Click here for information on ev3 Endovascular Inc. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stent and Protection Device | PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure. | Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation. | Posted | Number | participants | 30 Days |
|
|
30 Days
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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 | Intervention | PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood And Lymphatic System Disorders | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood And Lymphatic System Disorders | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Cihlar | Medtronic | 763-398-7932 | stephanie.a.cihlar@medtronic.com |
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| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Kingsport |
| Tennessee |
| United States |
| Exited study due to other reasons |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 553 |
| 1,500 |
| 258 |
| 1,500 |
| Cardiac disorder | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Ear And Labyrinth Disorders | Ear and labyrinth disorders | MedDRA (14.1) | Systematic Assessment |
|
| Eye disorder | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| General Disorders And Administrative Site Conditions | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hepatobiliary disorders | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Immune System Disorders | Immune system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Infections And Infestations | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Injury, Poisoning And Procedural Complications | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Investigations | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Metabolism And Nutrition Disorders | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
| Musculoskeletal And Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
|
| Nervous System Disorders | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Psychiatric Disorders | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
|
| Renal And Urinary Disorders | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Respiratory, Thoracic And Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Skin And Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Surgical And Medical Procedures | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
|
| Vascular Disorders | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Cardiac disorders | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Ear And Labyrinth Disorders | Ear and labyrinth disorders | MedDRA (14.1) | Systematic Assessment |
|
| Eye Disorders | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| General Disorders And Administrative Site Conditions | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hepatobiliary Disorders | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Immune System Disorders | Immune system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Infections And Infestations | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Injury, Poisoning And Procedural Complications | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Investigations | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Metabolism And Nutrition Disorders | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
| Musculoskeletal And Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
|
| Nervous System Disorders | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Psychiatric Disorders | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
|
| Renal And Urinary Disorders | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Reproductive System And Breast Disoders | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
|
| Respiratory, Thoracic And Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Skin And Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Surgical And Medical Procedures | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
|
| Vascular Disorders | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results without permission of the sponsor.
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |