N/A
N=1,200
Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
Carotid Artery Disease · Stroke · Amaurosis Fugax · Transient Ischemic Attack (TIA)
Bottom Line
View on ClinicalTrials.gov: NCT01445613 ↗Enrolled (actual)
1,200
Serious AEs
22.2%
Results posted
Apr 2016
Primary outcome: Primary: 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) — 4.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RX Acculink Carotid Stent System (RX Acculink) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
4.4 | — |
| PRIMARY Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days |
95.6 | — |
| SECONDARY Death and All Stroke |
3.4 | — |
| SECONDARY Composite of Peri-procedural Death and Stroke by Symptomatic Status |
5.8; 2.5 | — |
| SECONDARY Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status |
92.5; 96.8 | — |
| SECONDARY Composite of Peri-procedural Death and Stroke by Age |
3.4; 3.4 | — |
| SECONDARY Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age |
93.8; 95.8 | — |
| SECONDARY Freedom From Clinically Driven Target Lesion Revascularization |
99.3 | — |
| SECONDARY Freedom From Clinically Driven Target Lesion Revascularization |
99.3 | — |
| SECONDARY Freedom From Clinically Driven Target Lesion Revascularization |
99.3 | — |
| SECONDARY Clinical Success |
96.4 | — |
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
- 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 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.
Data sourced from ClinicalTrials.gov (NCT01445613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.