Overview

This trial is active, not recruiting.

Conditions carotid artery disease, stroke, amaurosis fugax, transient ischemic attack (tia)
Treatment rx acculink carotid stent system (rx acculink)
Sponsor Abbott Vascular
Start date October 2011
End date September 2014
Trial size 1200 participants
Trial identifier NCT01445613, 10-720

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
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)
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.

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)
time frame: 1 year (365 days)

Secondary Outcomes

Measure
Composite of peri-procedural death and stroke by symptomatic status
time frame: 30 days
Ipsilateral stroke
time frame: 2 years
Ipsilateral stroke
time frame: 3 years
Peri-procedural death and stroke plus ipsilateral stroke for octogenarians
time frame: 1 year
Peri-procedural death and stroke plus ipsilateral stroke for octogenarians
time frame: 2 years
Peri-procedural death and stroke plus ipsilateral stroke for octogenarians
time frame: 3 years
Annual rate of clinically driven target lesion revascularization (TLR)
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title CANOPY: Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
Principal investigator D. Christopher Metzger, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Abbott Vascular.