Carotid Artery DiseaseCANOPYNCT01445613
Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
A study testing RX Acculink Carotid Stent System (RX Acculink) in people with Carotid Artery Disease and Stroke, run by Abbott Medical Devices at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Disease, Stroke, Amaurosis Fugax
- What is being tested?
- RX Acculink Carotid Stent System (RX Acculink)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,203 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be ≥ 18 years of age.
- Subject does not have any condition that limits their anticipated survival to less than 3 years.
- Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure.
- 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-
- 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.
- Subject with all the following target vessel characteristics:
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- Discrete lesion in internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
- Vessel diameter ≥ 4.0 mm and ≤ 9.0 mm from reference or contralateral artery.
- Absence of excessive vessel tortuosity that would impede delivery of devices.
- Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure.
Who cannot join
- Subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (CEA).
- 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.
- Subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions.
- Subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such.
- Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- RX Acculink Carotid Stent System (RX Acculink)
- Keywords
- Carotid, Stent, Carotid Endarterectomy
- Medical subject headings
- Carotid Artery Diseases, Stroke, Amaurosis Fugax, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RX Acculink Carotid Stent System (RX Acculink)Device
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
| Study group | Role | What they receive |
|---|---|---|
| RX Acculink Carotid Stent System (RX Acculink) | Other | Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink. Receives: Device: RX Acculink Carotid Stent System (RX Acculink) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0 to 365 days
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days
Measured: 365 days
Secondary outcomes (9)
Death and All Stroke
Measured: 30 Days
Composite of Peri-procedural Death and Stroke by Symptomatic Status
Measured: 30 days
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status
Measured: 365 days
Composite of Peri-procedural Death and Stroke by Age
Measured: 30 days
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age
Measured: 365 days
Freedom From Clinically Driven Target Lesion Revascularization
Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion.
Measured: 30 days
Freedom From Clinically Driven Target Lesion Revascularization
Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion.
Measured: 180 days
Freedom From Clinically Driven Target Lesion Revascularization
Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion.
Measured: 365 days
Clinical Success
Clinical success is defined as the attainment of < 50% residual stenosis of the target lesion and absence of a death or stroke 30-day post-procedure.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2014
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carotid Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- D. Christopher Metzger, MD, Principal investigator, Wellmont Holston Valley Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445613
- Sponsor's protocol ID
- 10-720
- Acronym
- CANOPY
- Status last verified
- Jul 2016
- First submitted
- 30 Sep 2011
- Last updated
- 12 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CANOPY: Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT01445613
- Acronym / sponsor ID
- CANOPY / 10-720
- Keywords
- Carotid, Stent, Carotid Endarterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,203 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 4 Oct 2011 (estimated)
- Results
- Posted 12 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RX Acculink Carotid Stent System (RX Acculink) | Other | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject must be ≥ 18 years of age.
- Subject does not have any condition that limits their anticipated survival to less than 3 years.
- Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure.
- 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-
- 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.
Key exclusion criteria (6 listed)
- Subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (CEA).
- 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.
- Subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions.
- Subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such.
- Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | RX Acculink Carotid Stent System (RX Acculink) |
Primary outcome
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: 0 to 365 days
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days
Time frame: 365 days
9 secondary outcomes
Death and All Stroke
Time frame: 30 Days
Composite of Peri-procedural Death and Stroke by Symptomatic Status
Time frame: 30 days
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status
Time frame: 365 days
Composite of Peri-procedural Death and Stroke by Age
Time frame: 30 days
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age
Time frame: 365 days
Freedom From Clinically Driven Target Lesion Revascularization
Time frame: 30 days
Freedom From Clinically Driven Target Lesion Revascularization
Time frame: 180 days
Freedom From Clinically Driven Target Lesion Revascularization
Time frame: 365 days
Clinical Success
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D. Christopher Metzger, MD principal investigator
Wellmont Holston Valley Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RX Acculink Carotid Stent System (RX Acculink) in people with Carotid Artery Disease and Stroke, run by Abbott Medical Devices at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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: 0 to 365 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2016.