Carotid Artery Stenting Outcomes in the Standard Risk Pop... | NCT01445613

NCT01445613

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Device: RX Acculink Carotid Stent System (RX Acculink)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.	RX Acculink Carotid Stent System (RX Acculink)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)		0 to 365 days
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days		365 days

Secondary Outcomes

Measure	Description	Time Frame
Death and All Stroke		30 Days
Composite of Peri-procedural Death and Stroke by Symptomatic Status		30 days
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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:
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.
Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure.

Exclusion Criteria:

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.

Name	Affiliation	Role
D. Christopher Metzger, MD	Wellmont Holston Valley Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Abbott Vascular		Santa Clara	California	95054	United States

ID	Title	Description
FG000	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 (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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 (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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)

FAS population

Posted

Mean

Standard Error

percentage of participants

0 to 365 days

ID	Title	Description
OG000	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 (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.

Units	Counts
Participants

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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 (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hematoma	General disorders	Abbott categories	Systematic Assessment	Access Site Complication

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Arrhythmia (Includes Brady And Tachy)	General disorders	Abbott categories	Systematic Assessment	Procedure Related

ID	Term
D002340	Carotid Artery Diseases
D020521	Stroke
D020757	Amaurosis Fugax
D002546	Ischemic Attack, Transient

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases