Clinical trial NCT01445613: Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
Official title: CANOPY: Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Artery Disease
Stroke
Amaurosis Fugax
Transient Ischemic Attack (TIA)
Keywords: Carotid
Stent
Carotid Endarterectomy
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-10-04
Enrollment: 1203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
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)
timeFrame: 0 to 365 days
measure: Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days
timeFrame: 365 days
Secondary outcomes:
measure: Death and All Stroke
timeFrame: 30 Days
measure: Composite of Peri-procedural Death and Stroke by Symptomatic Status
timeFrame: 30 days
measure: Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status
timeFrame: 365 days
measure: Composite of Peri-procedural Death and Stroke by Age
timeFrame: 30 days
measure: Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age
timeFrame: 365 days
measure: Freedom From Clinically Driven Target Lesion Revascularization
timeFrame: 30 days
measure: Freedom From Clinically Driven Target Lesion Revascularization
timeFrame: 180 days
measure: Freedom From Clinically Driven Target Lesion Revascularization
timeFrame: 365 days
measure: Clinical Success
timeFrame: 30 days
Other outcomes:
Locations:
city: Santa Clara
country: United States
facility: Abbott Vascular
state: California
Study officials:
affiliation: Wellmont Holston Valley Medical Center
name: D. Christopher Metzger, MD
role: PRINCIPAL_INVESTIGATOR
References: