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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01445613
First Posted: October 4, 2011
Last Update Posted: August 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abbott Vascular
September 30, 2011
October 4, 2011
December 3, 2015
April 12, 2016
August 12, 2016
October 2011
December 2014   (Final data collection date for primary outcome measure)
  • 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 ]
Composite rate of peri-procedural death and stroke, plus ipsilateral stroke between day 31 and 1 year (365 days) [ Time Frame: 1 year (365 days) ]
Complete list of historical versions of study NCT01445613 on ClinicalTrials.gov Archive Site
  • 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.
  • Composite of Peri-procedural Death and Stroke by Symptomatic Status [ Time Frame: 30 days ]
  • Ipsilateral stroke [ Time Frame: 2 years ]
  • Ipsilateral stroke [ Time Frame: 3 years ]
  • Peri-procedural death and stroke plus ipsilateral stroke for octogenarians [ Time Frame: 1 year ]
  • Peri-procedural death and stroke plus ipsilateral stroke for octogenarians [ Time Frame: 2 years ]
  • Peri-procedural death and stroke plus ipsilateral stroke for octogenarians [ Time Frame: 3 years ]
  • Annual rate of clinically driven target lesion revascularization (TLR) [ Time Frame: 3 years ]
Not Provided
Not Provided
 
Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
CANOPY: Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Carotid Artery Disease
  • Stroke
  • Amaurosis Fugax
  • Transient Ischemic Attack (TIA)
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.
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.
Intervention: Device: RX Acculink Carotid Stent System (RX Acculink)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1203
March 2016
December 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01445613
10-720
No
Not Provided
Plan to Share IPD: No
Abbott Vascular
Abbott Vascular
Not Provided
Principal Investigator: D. Christopher Metzger, MD Wellmont Holston Valley Medical Center
Abbott Vascular
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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