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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01445613
Other study ID # 10-720
Secondary ID
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


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
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