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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,203
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
Abbott Vascular
Santa Clara, California, United States
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
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
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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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.
Time frame: 30 days