Trial record 1 of 6 for:    CANOPY
Previous Study | Return to List | Next Study

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01445613
First received: September 30, 2011
Last updated: April 2, 2014
Last verified: April 2014

September 30, 2011
April 2, 2014
October 2011
December 2014   (final data collection date for primary outcome 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) ] [ Designated as safety issue: Yes ]
Composite rate of peri-procedural death and stroke, plus ipsilateral stroke between day 31 and 1 year (365 days) [ Time Frame: 1 year (365 days) ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01445613 on ClinicalTrials.gov Archive Site
  • Composite of peri-procedural death and stroke by symptomatic status [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Ipsilateral stroke [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Ipsilateral stroke [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Peri-procedural death and stroke plus ipsilateral stroke for octogenarians [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Peri-procedural death and stroke plus ipsilateral stroke for octogenarians [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Peri-procedural death and stroke plus ipsilateral stroke for octogenarians [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Annual rate of clinically driven target lesion revascularization (TLR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
CANOPY: Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Carotid Artery Disease
  • Stroke
  • Amaurosis Fugax
  • Transient Ischemic Attack (TIA)
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.
RX Acculink Carotid Stent System
Intervention: Device: RX Acculink Carotid Stent System (RX Acculink)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1200
December 2016
December 2014   (final data collection date for primary outcome measure)

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 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01445613
10-720
No
Abbott Vascular
Abbott Vascular
Not Provided
Principal Investigator: D. Christopher Metzger, MD Wellmont Holston Valley Medical Center
Abbott Vascular
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP