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

Study Description

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Brief Summary:

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.

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 Design

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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

Arms and Interventions

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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.	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.

Outcome Measures

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Primary Outcome Measures :

1. 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 ]
2. Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days [ Time Frame: 365 days ]

Secondary Outcome Measures :

1. Death and All Stroke [ Time Frame: 30 Days ]
2. Composite of Peri-procedural Death and Stroke by Symptomatic Status [ Time Frame: 30 days ]
3. Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status [ Time Frame: 365 days ]
4. Composite of Peri-procedural Death and Stroke by Age [ Time Frame: 30 days ]
5. Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age [ Time Frame: 365 days ]
6. 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.
7. 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.
8. 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.
9. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Locations

United States, California
Abbott Vascular
Santa Clara, California, United States, 95054

Sponsors and Collaborators

Abbott Vascular

Investigators

Principal Investigator:	D. Christopher Metzger, MD	Wellmont Holston Valley Medical Center

More Information

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Responsible Party:	Abbott Vascular
ClinicalTrials.gov Identifier:	NCT01445613 History of Changes
Other Study ID Numbers:	10-720
First Posted:	October 4, 2011
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