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

Primary Purpose

Carotid Artery Disease, Stroke, Amaurosis Fugax

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RX Acculink Carotid Stent System (RX Acculink)
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Artery Disease focused on measuring Carotid, Stent, Carotid Endarterectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Abbott Vascular

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

RX Acculink Carotid Stent System (RX Acculink)

Arm Description

Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.

Outcomes

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)
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days

Secondary Outcome Measures

Death and All Stroke
Composite of Peri-procedural Death and Stroke by Symptomatic Status
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status
Composite of Peri-procedural Death and Stroke by Age
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age
Freedom From Clinically Driven Target Lesion Revascularization
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
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
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
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.

Full Information

First Posted
September 30, 2011
Last Updated
July 13, 2016
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01445613
Brief Title
Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
Acronym
CANOPY
Official Title
CANOPY: Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Disease, Stroke, Amaurosis Fugax, Transient Ischemic Attack (TIA)
Keywords
Carotid, Stent, Carotid Endarterectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RX Acculink Carotid Stent System (RX Acculink)
Arm Type
Other
Arm Description
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
Intervention Type
Device
Intervention Name(s)
RX Acculink Carotid Stent System (RX Acculink)
Intervention Description
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
Primary Outcome Measure Information:
Title
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
Title
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days
Time Frame
365 days
Secondary Outcome Measure Information:
Title
Death and All Stroke
Time Frame
30 Days
Title
Composite of Peri-procedural Death and Stroke by Symptomatic Status
Time Frame
30 days
Title
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status
Time Frame
365 days
Title
Composite of Peri-procedural Death and Stroke by Age
Time Frame
30 days
Title
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age
Time Frame
365 days
Title
Freedom From Clinically Driven Target Lesion Revascularization
Description
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.
Time Frame
30 days
Title
Freedom From Clinically Driven Target Lesion Revascularization
Description
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.
Time Frame
180 days
Title
Freedom From Clinically Driven Target Lesion Revascularization
Description
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.
Time Frame
365 days
Title
Clinical Success
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D. Christopher Metzger, MD
Organizational Affiliation
Wellmont Holston Valley Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abbott Vascular
City
Santa Clara
State/Province
California
ZIP/Postal Code
95054
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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