Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy

Stroke Clinical Trial

— CANOPY  

Official title:

CANOPY: Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01445613
• Other study ID #: 10-720
• Status: Active, not recruiting
• Phase: N/A
• First received: September 30, 2011
• Last updated: March 20, 2015
• Start date: October 2011
• Est. completion date: December 2016

Study information

• Verified date: March 2015
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: December 2016
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amaurosis Fugax
• Carotid Artery Disease
• Carotid Artery Diseases
• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack (TIA)

Intervention

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.

Locations

Country	Name	City	State
United States	Abbott Vascular	Santa Clara	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)		1 year (365 days)	Yes
Secondary	Composite of peri-procedural death and stroke by symptomatic status		30 days	Yes
Secondary	Ipsilateral stroke		2 years	No
Secondary	Ipsilateral stroke		3 years	No
Secondary	Peri-procedural death and stroke plus ipsilateral stroke for octogenarians		1 year	Yes
Secondary	Peri-procedural death and stroke plus ipsilateral stroke for octogenarians		2 years	Yes
Secondary	Peri-procedural death and stroke plus ipsilateral stroke for octogenarians		3 years	Yes
Secondary	Annual rate of clinically driven target lesion revascularization (TLR)		3 years	No