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

NCT ID: NCT01445613

Last Updated: 2016-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2016-03-31

Brief 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.

Conditions

Carotid Artery Disease; Stroke; Amaurosis Fugax; Transient Ischemic Attack (TIA)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

RX Acculink Carotid Stent System (RX Acculink)

Intervention Type: DEVICE

Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

D. Christopher Metzger, MD

Role: PRINCIPAL_INVESTIGATOR

Wellmont Holston Valley Medical Center

Locations

Abbott Vascular

Santa Clara, California, United States

Countries

United States

Other Identifiers

10-720

Identifier Type: -

Identifier Source: org_study_id