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

NCT01445613 | Completed Results

• 1 other identifier: 10-720
• Study Type: interventional
• Target: 1,203
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Disease; Stroke; Amaurosis Fugax; Transient Ischemic Attack (TIA)

Keywords

Carotid; Stent; Carotid Endarterectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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

Study Arms (1)

RX Acculink Carotid Stent System (RX Acculink)

OTHER

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)

Interventions

RX Acculink Carotid Stent System (RX Acculink) DEVICE

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott Vascular

Santa Clara, California, 95054, United States

Location

MeSH Terms

Conditions

Carotid Artery Diseases; Stroke; Amaurosis Fugax; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Ischemia

Results Point of Contact

• Title: David R Rutledge
• Organization: Abbott Vascular

david.rutledge@av.abbott.com

(408) 845-3820

Study Officials

• D. Christopher Metzger, MD

  Wellmont Holston Valley Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 4, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2016
• Last Updated: August 12, 2016
• Results First Posted: April 12, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)