Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy (CANOPY)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: September 30, 2011
Last updated: April 2, 2014
Last verified: April 2014
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.
Carotid Artery Disease
Transient Ischemic Attack (TIA)
Device: RX Acculink Carotid Stent System (RX Acculink)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||CANOPY: Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
Primary Outcome Measures:
- 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) [ Time Frame: 1 year (365 days) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Composite of peri-procedural death and stroke by symptomatic status [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Ipsilateral stroke [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Ipsilateral stroke [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Peri-procedural death and stroke plus ipsilateral stroke for octogenarians [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Peri-procedural death and stroke plus ipsilateral stroke for octogenarians [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Peri-procedural death and stroke plus ipsilateral stroke for octogenarians [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Annual rate of clinically driven target lesion revascularization (TLR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
RX Acculink Carotid Stent System
Device: RX Acculink Carotid Stent System (RX Acculink)
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Subject must be ≥ 18 years of age.
- Subject does not have any condition that limits their anticipated survival to less than 3 years.
- Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure.
- 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-
- 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.
Subject with all the following target vessel characteristics:
- Discrete lesion in internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
- Vessel diameter ≥ 4.0 mm and ≤ 9.0 mm from reference or contralateral artery.
- Absence of excessive vessel tortuosity that would impede delivery of devices.
- Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure.
- Subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (CEA).
- 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.
- Subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions.
- Subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such.
- Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01445613
|Santa Clara, California, United States, 95054 |
||D. Christopher Metzger, MD
||Wellmont Holston Valley Medical Center
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 30, 2011
||April 2, 2014
||United States: Institutional Review Board
Keywords provided by Abbott Vascular:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 31, 2014
Carotid Artery Diseases
Ischemic Attack, Transient
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms