Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy (CANOPY)
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ClinicalTrials.gov Identifier: NCT01445613 |
Recruitment Status
:
Completed
First Posted
: October 4, 2011
Results First Posted
: April 12, 2016
Last Update Posted
: August 12, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carotid Artery Disease Stroke Amaurosis Fugax Transient Ischemic Attack (TIA) | Device: RX Acculink Carotid Stent System (RX Acculink) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1203 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | CANOPY: Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | March 2016 |
Arm | Intervention/treatment |
---|---|
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.
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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.
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- 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: 0 to 365 days ]
- Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days [ Time Frame: 365 days ]
- Death and All Stroke [ Time Frame: 30 Days ]
- Composite of Peri-procedural Death and Stroke by Symptomatic Status [ Time Frame: 30 days ]
- Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status [ Time Frame: 365 days ]
- Composite of Peri-procedural Death and Stroke by Age [ Time Frame: 30 days ]
- Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age [ Time Frame: 365 days ]
- Freedom From Clinically Driven Target Lesion Revascularization [ Time Frame: 30 days ]Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion.
- Freedom From Clinically Driven Target Lesion Revascularization [ Time Frame: 180 days ]Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion.
- Freedom From Clinically Driven Target Lesion Revascularization [ Time Frame: 365 days ]Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion.
- Clinical Success [ Time Frame: 30 days ]Clinical success is defined as the attainment of < 50% residual stenosis of the target lesion and absence of a death or stroke 30-day post-procedure.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
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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.
Exclusion Criteria:
- 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 international normalized ratio (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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01445613
United States, California | |
Abbott Vascular | |
Santa Clara, California, United States, 95054 |
Principal Investigator: | D. Christopher Metzger, MD | Wellmont Holston Valley Medical Center |
Responsible Party: | Abbott Vascular |
ClinicalTrials.gov Identifier: | NCT01445613 History of Changes |
Other Study ID Numbers: |
10-720 |
First Posted: | October 4, 2011 Key Record Dates |
Results First Posted: | April 12, 2016 |
Last Update Posted: | August 12, 2016 |
Last Verified: | July 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Abbott Vascular:
Carotid Stent Carotid Endarterectomy |
Additional relevant MeSH terms:
Ischemic Attack, Transient Carotid Artery Diseases Blindness Amaurosis Fugax Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Vision Disorders Sensation Disorders Neurologic Manifestations Eye Diseases Signs and Symptoms |