Peripheral Vascular Disease
Conditions
Keywords
Peripheral Vascular Disease, Femoral Artery, Drug-Eluting Stent
Brief summary
The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system.
Interventions
Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
Sponsors
Cook Group Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries * Patient has atherosclerotic lesion of the above-the-knee femoropopliteal artery
Exclusion criteria
* Patient is \< 18 years of age * Patient unable to complete required follow-up assessments * Patient unwilling to sign and date the informed consent * Simultaneous participation in another investigational drug or device study * Pregnant, breastfeeding or planning to become pregnant in the next 5 years * Additional medical/anatomical restrictions as specified in the Clinical Investigation Plan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Percent Change in Stent Length Upon Deployment | Immediately following completion of the stent placement procedure |
Countries
Australia, Germany, New Zealand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent |
|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 6 / 40 |
Outcome results
Primary
Mean Percent Change in Stent Length Upon Deployment
Time frame: Immediately following completion of the stent placement procedure
Population: There were 63 implanted stents, an assessment of stent length change was not available for 2 stents.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent | Mean Percent Change in Stent Length Upon Deployment | -1.0 percentage of change in stent length | Standard Deviation 2.1 |
p-value: <0.0195% CI: [-1.5, -0.4]two one-sided t-tests