Zilver PTX Delivery System | NCT02271529

Zilver PTX Delivery System | NCT02271529 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Drug Eluting Stent	Experimental	Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent	Device: Zilver® PTX® Drug-Eluting Peripheral Stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zilver® PTX® Drug-Eluting Peripheral Stent	Device	Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.	Drug Eluting Stent

Outcomes Module

Measure	Description	Time Frame
Mean Percent Change in Stent Length Upon Deployment		Immediately following completion of the stent placement procedure

Contacts/Locations Module

Name	Affiliation	Role
Andrew Holden, MD	Auckland District Health Board	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Frankston Hospital		Frankston		Vic 3199	Australia
Princess Alexandra Hospital

ID	Title	Description
FG000	Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent	Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00040 subjects
COMPLETED		FG00039 subjects
NOT COMPLETED		FG0001 subjects

Type	Comment	Reasons
Withdrawal by Subject		FG0001 subjects

Baseline Characteristics Module

ID	Title	Description
BG000	Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent	Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.

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

Mean Percent Change in Stent Length Upon Deployment

There were 63 implanted stents, an assessment of stent length change was not available for 2 stents.

Posted

Mean

Standard Deviation

percentage of change in stent length

Immediately following completion of the stent placement procedure

Stents

Participants

ID	Title	Description
OG000	Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent	Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.

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	Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent	Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hematoma	Injury, poisoning and procedural complications		Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Scott Snyder, Director, Clinical Affairs	Cook Research Incorporated	765-463-7537		SSnyder@medinst.com

Condition Browse Module

ID	Term
D016491	Peripheral Vascular Diseases

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000		two one-sided t-tests		<0.01		Mean percent change	-1.0			2-Sided	95	-1.5	-0.4				Yes	Non-Inferiority or Equivalence	Under the assumption that the mean percent change in stent length upon deployment being 0.2% with a standard deviation of 4%, type I error of 0.05, and two one-sided t-tests, a sample size of at least 30 stents provides power > 0.90 to determine that the mean length change of stents deployed with the thumbwheel delivery system is within +/-10%.