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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01445613
First received: September 30, 2011
Last updated: July 13, 2016
Last verified: July 2016
  Purpose
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 Intervention
Carotid Artery Disease
Stroke
Amaurosis Fugax
Transient Ischemic Attack (TIA)
Device: RX Acculink Carotid Stent System (RX Acculink)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CANOPY: Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

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: 0 to 365 days ] [ Designated as safety issue: Yes ]
  • Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days [ Time Frame: 365 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Death and All Stroke [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  • Composite of Peri-procedural Death and Stroke by Symptomatic Status [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status [ Time Frame: 365 days ] [ Designated as safety issue: Yes ]
  • Composite of Peri-procedural Death and Stroke by Age [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age [ Time Frame: 365 days ] [ Designated as safety issue: Yes ]
  • Freedom From Clinically Driven Target Lesion Revascularization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 1203
Study Start Date: October 2011
Study Completion Date: March 2016
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01445613

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

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01445613     History of Changes
Other Study ID Numbers: 10-720 
Study First Received: September 30, 2011
Results First Received: December 3, 2015
Last Updated: July 13, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
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

ClinicalTrials.gov processed this record on September 30, 2016