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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Carotid Artery Disease; Amaurosis Fugax; Transient Ischemic Attack (TIA)
• Intervention / Treatment: Device: RX Acculink Carotid Stent System (RX Acculink)

• Study Type: Interventional
• Enrollment (Actual): 1203
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	0 to 365 days
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days	365 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death and All Stroke		30 Days
Composite of Peri-procedural Death and Stroke by Symptomatic Status		30 days
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status		365 days
Composite of Peri-procedural Death and Stroke by Age		30 days
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age		365 days
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.	30 days
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.	180 days
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.	365 days
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.	30 days

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: D. Christopher Metzger, MD, Wellmont Holston Valley Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: September 30, 2011
• First Submitted That Met QC Criteria: October 3, 2011
• First Posted (Estimate): October 4, 2011

Study Record Updates

• Last Update Posted (Estimate): August 12, 2016
• Last Update Submitted That Met QC Criteria: July 13, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Stent; Carotid Endarterectomy; Carotid
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Brain Ischemia; Sensation Disorders; Vision Disorders; Ischemic Attack, Transient; Carotid Artery Diseases; Blindness; Amaurosis Fugax
• Other Study ID Numbers: 10-720

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No