Peripheral Arterial Disease
Conditions
Keywords
Peripheral Vascular Disease, Femoral Artery, Popliteal Artery, Drug-Eluting Stent
Brief summary
The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.
Interventions
Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
Sponsors
Cook Research 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 signed and dated the informed consent. * Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries. * Patient agrees to return for the required follow-up assessments.
Exclusion criteria
* Patient is \< 18 years of age. * Patient has significant stenosis of inflow tract not successfully treated before this procedure. * Patient lacks at least one patent vessel of runoff with \< 50% stenosis throughout its course.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients Without Target Lesion Revascularization (TLR) | 1 year | A reintervention performed for ≥ 50 % diameter stenosis within ± 5 mm proximal and /or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral arterial disease (PAD) following the initial procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Drug-Eluting Stent Zilver® PTX® Drug-Eluting Peripheral Stent: Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries. | 200 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 32 |
| Overall Study | Lost to Follow-up | 16 |
| Overall Study | Other type of endpoint met | 2 |
| Overall Study | Withdrawal by Subject | 35 |
Baseline characteristics
| Characteristic | Drug-Eluting Stent |
|---|---|
| Age, Continuous | 67.9 years STANDARD_DEVIATION 9.5 |
| Diabetes | 92 Participants |
| Hypercholesterolemia | 173 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black | 22 Participants |
| Race/Ethnicity, Customized Black/Caucasian or White | 1 Participants |
| Race/Ethnicity, Customized Caucasian or White | 165 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 10 Participants |
| Region of Enrollment United States | 200 participants |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 126 Participants |
| Smoking Status Never smoked | 31 Participants |
| Smoking Status Quit smoking | 86 Participants |
| Smoking Status Still smoking | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 32 / 200 |
| other Total, other adverse events | 46 / 200 |
| serious Total, serious adverse events | 154 / 200 |
Outcome results
Primary
Patients Without Target Lesion Revascularization (TLR)
A reintervention performed for ≥ 50 % diameter stenosis within ± 5 mm proximal and /or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral arterial disease (PAD) following the initial procedure.
Time frame: 1 year
Population: The result was calculated using the Kaplan-Meier method (with Greenwood's formula for standard error).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug-Eluting Stent | Patients Without Target Lesion Revascularization (TLR) | 186 Participants |
95% CI: [0.881, 0.956]