Stroke Clinical Trial
— CANOPYOfficial title:
CANOPY: Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
Verified date | March 2015 |
Source | Abbott Vascular |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The objective of the CANOPY trial is to assess the continued safety and effectiveness of the RX Acculink Carotid Stent System under commercial use in subjects at standard risk for adverse events from Carotid Endarterectomy (CEA) enrolled by physicians with a range of carotid stenting experience.
Status | Active, not recruiting |
Enrollment | 1200 |
Est. completion date | December 2016 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Abbott Vascular | Santa Clara | California |
Lead Sponsor | Collaborator |
---|---|
Abbott Vascular |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite rate of peri-procedural (within 30 days of the procedure) death and stroke, plus ipsilateral stroke between day 31 and 1 year (365 days) | 1 year (365 days) | Yes | |
Secondary | Composite of peri-procedural death and stroke by symptomatic status | 30 days | Yes | |
Secondary | Ipsilateral stroke | 2 years | No | |
Secondary | Ipsilateral stroke | 3 years | No | |
Secondary | Peri-procedural death and stroke plus ipsilateral stroke for octogenarians | 1 year | Yes | |
Secondary | Peri-procedural death and stroke plus ipsilateral stroke for octogenarians | 2 years | Yes | |
Secondary | Peri-procedural death and stroke plus ipsilateral stroke for octogenarians | 3 years | Yes | |
Secondary | Annual rate of clinically driven target lesion revascularization (TLR) | 3 years | No |
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