Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy "CANOPY"

Completed

Phase N/A Results

Update History

14 Apr '16
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Subject must be ≥ 18 years of age. 2. Subject does not have any condition that limits their anticipated survival to less than 3 years. 3. Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure. 4. Subjects with neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram - OR- 5. Subjects without neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram. 6. Subject with all the following target vessel characteristics: 1. Discrete lesion in internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA). 2. Vessel diameter ≥ 4.0 mm and ≤ 9.0 mm from reference or contralateral artery. 3. Absence of excessive vessel tortuosity that would impede delivery of devices. 7. Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure. Exclusion Criteria: 1. Subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (CEA). 2. Subject with Hgb <10.g/dl or platelet count < 125,000 µl or has heparin-associated thrombocytopenia. For subjects on Coumadin (Warfarin) and for subjects with a platelet or coagulation disorder: Has an international normalized ratio (INR) > 1.5. 3. Subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions. 4. Subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such. 5. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. 6. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
Old
Inclusion Criteria: 1. Subject must be ≥ 18 years of age. 2. Subject does not have any condition that limits their anticipated survival to less than 3 years. 3. Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure. 4. Subjects with neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram - OR- 5. Subjects without neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram. 6. Subject with all the following target vessel characteristics: 1. Discrete lesion in internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA). 2. Vessel diameter ≥ 4.0 mm and ≤ 9.0 mm from reference or contralateral artery. 3. Absence of excessive vessel tortuosity that would impede delivery of devices. 7. Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure. Exclusion Criteria: 1. Subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (CEA). 2. Subject with Hgb <10.g/dl or platelet count < 125,000 µl or has heparin-associated thrombocytopenia. For subjects on Coumadin (Warfarin) and for subjects with a platelet or coagulation disorder: Has an international normalized ratio (INR) > 1.5. 3. Subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions. 4. Subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such. 5. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. 6. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
25 Mar '15
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Subject must be ≥ 18 years of age. 2. Subject does not have any condition that limits their anticipated survival to less than 3 years. 3. Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure. 4. Subjects with neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram - OR- 5. Subjects without neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram. 6. Subject with all the following target vessel characteristics: 1. Discrete lesion in internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA). 2. Vessel diameter ≥ 4.0 mm and ≤ 9.0 mm from reference or contralateral artery. 3. Absence of excessive vessel tortuosity that would impede delivery of devices. 7. Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure. Exclusion Criteria: 1. Subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (CEA). 2. Subject with Hgb <10.g/dl or platelet count < 125,000 µl or has heparin-associated thrombocytopenia. For subjects on Coumadin (Warfarin) and for subjects with a platelet or coagulation disorder: Has an international normalized ratio (INR) > 1.5. 3. Subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions. 4. Subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such. 5. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. 6. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
Old
Inclusion Criteria: 1. Subject must be ≥ 18 years of age. 2. Subject does not have any condition that limits their anticipated survival to less than 3 years. 3. Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure. 4. Subjects with neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram - OR- 5. Subjects without neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram. 6. Subject with all the following target vessel characteristics: 1. Discrete lesion in internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA). 2. Vessel diameter ≥ 4.0 mm and ≤ 9.0 mm from reference or contralateral artery. 3. Absence of excessive vessel tortuosity that would impede delivery of devices. 7. Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure. Exclusion Criteria: 1. Subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (CEA). 2. Subject with Hgb , 10.g/dl or platelet count < 125,000 µl or has heparin-associated thrombocytopenia. For subjects on Coumadin (Warfarin) and for subjects with a platelet or coagulation disorder: Has an international normalized ratio (INR) > 1.5. 3. Subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions. 4. Subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such. 5. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. 6. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
8 Aug '14
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Subject must be ≥ 18 years of age. 2. Subject does not have any condition that limits their anticipated survival to less than 3 years. 3. Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure. 4. Subjects with neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram - OR- 5. Subjects without neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram. 6. Subject with all the following target vessel characteristics: 1. Discrete lesion in internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA). 2. Vessel diameter ≥ 4.0 mm and ≤ 9.0 mm from reference or contralateral artery. 3. Absence of excessive vessel tortuosity that would impede delivery of devices. 7. Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure. Exclusion Criteria: 1. Subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (CEA). 2. Subject with Hgb , 10.g/dl or platelet count < 125,000 µl or has heparin-associated thrombocytopenia. For subjects on Coumadin (Warfarin) and for subjects with a platelet or coagulation disorder: Has an international normalized ratio (INR) > 1.5. 3. Subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions. 4. Subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such. 5. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. 6. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
Old
Inclusion Criteria: 1. Subject must be ≥ 18 years of age. 2. Subject does not have any condition that limits their anticipated survival to less than 3 years. 3. Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure. 4. Subjects with neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram - OR- 5. Subjects without neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram. 6. Subject with all the following target vessel characteristics: 1. Discrete lesion in internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA). 2. Vessel diameter ≥ 4.0 mm and ≤ 9.0 mm from reference or contralateral artery. 3. Absence of excessive vessel tortuosity that would impede delivery of devices. 7. Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure. Exclusion Criteria: 1. Subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (CEA). 2. Subject with Hgb , 10.g/dl or platelet count < 125,000 µl or has heparin-associated thrombocytopenia. For subjects on Coumadin (Warfarin) and for subjects with a platelet or coagulation disorder: Has an INR > 1.5. 3. Subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions. 4. Subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such. 5. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. 6. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
5 Apr '14
A location was updated in Santa Clara.
New
The overall status was removed for Abbott Vascular.
12 Jan '13
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Subject must be ≥ 18 years of age. 2. Subject does not have any condition that limits their anticipated survival to less than 3 years. 3. Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure. 4. Subjects with neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram - OR- 5. Subjects without neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram. 6. Subject with all the following target vessel characteristics: 1. Discrete lesion in internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA). 2. Vessel diameter ≥ 4.0 mm and ≤ 9.0 mm from reference or contralateral artery. 3. Absence of excessive vessel tortuosity that would impede delivery of devices. 7. Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure. Exclusion Criteria: 1. Subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (CEA). 2. Subject with Hgb , 10.g/dl or platelet count < 125,000 µl or has heparin-associated thrombocytopenia. For subjects on Coumadin (Warfarin) and for subjects with a platelet or coagulation disorder: Has an INR > 1.5. 3. Subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions. 4. Subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such. 5. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. 6. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
Old
Inclusion Criteria: 1. Subject must be ≥ 18 years of age. 2. Subject does not have any condition that limits their anticipated survival to less than 3 years. 3. Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure. 4. Subjects with neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram - OR- 5. Subjects without neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram. 6. Subject with all the following target vessel characteristics: 1. Discrete lesion in internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA). 2. Vessel diameter > 4.0 mm and < 9.0 mm from reference or contralateral artery. 3. Absence of excessive vessel tortuosity that would impede delivery of devices. 7. Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure. Exclusion Criteria: 1. Subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (CEA). 2. Subject has Hgb < 10 g/dl, platelet count < 125,000/μl, uncorrected INR > 1.5, bleeding time >1 minute beyond upper limit normal, or heparin-associated thrombocytopenia. 3. Subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions. 4. Subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such. 5. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. 6. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
8 Nov '11
A location was updated in Santa Clara.
New
The overall status was removed for Abbott Vascular.