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Trial record 1 of 1 for:
NCT01445613
Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy (CANOPY)
This study has been completed.
Sponsor:
Abbott Vascular
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
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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: | 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 ]
- Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days [ Time Frame: 365 days ]
Secondary Outcome Measures:
- 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.
| 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) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
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 |
| 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 June 27, 2017