Trial Outcomes & Findings for Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery (NCT NCT00120406)
NCT ID: NCT00120406
Last Updated: 2014-08-11
Results Overview
Event-free survival is defined as freedom from the major adverse events of death, target lesion revascularization, target limb ischemia requiring surgical intervention (bypass or amputation of toe, foot or leg), surgical repair of the target vessel (e.g., dissection requiring surgery), and from worsening of the Rutherford classification by 2 classes or to class 5 or 6. Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and Event-free survival is based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
474 participants
Primary outcome timeframe
12 months
Results posted on
2014-08-11
Participant Flow
Participant milestones
| Measure |
Zilver PTX
Zilver® PTX™ Drug Eluting Vascular Stent
|
PTA (Control)
Percutaneous balloon angioplasty
|
|---|---|---|
|
Overall Study
STARTED
|
236
|
238
|
|
Overall Study
COMPLETED
|
217
|
222
|
|
Overall Study
NOT COMPLETED
|
19
|
16
|
Reasons for withdrawal
| Measure |
Zilver PTX
Zilver® PTX™ Drug Eluting Vascular Stent
|
PTA (Control)
Percutaneous balloon angioplasty
|
|---|---|---|
|
Overall Study
Death
|
9
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
|
Overall Study
received non-study stent
|
0
|
2
|
|
Overall Study
patient moved but has not withdrawn
|
0
|
1
|
Baseline Characteristics
Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
Baseline characteristics by cohort
| Measure |
Zilver PTX
n=236 Participants
Zilver® PTX™ Drug Eluting Vascular Stent
|
PTA (Control)
n=238 Participants
Percutaneous balloon angioplasty
|
Total
n=474 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 9.6 • n=93 Participants
|
67.7 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
67.8 years
STANDARD_DEVIATION 10.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=93 Participants
|
86 Participants
n=4 Participants
|
167 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
155 Participants
n=93 Participants
|
152 Participants
n=4 Participants
|
307 Participants
n=27 Participants
|
|
BMI
|
28.4 kg/m^2
STANDARD_DEVIATION 5.3 • n=93 Participants
|
28.2 kg/m^2
STANDARD_DEVIATION 5.6 • n=4 Participants
|
28.3 kg/m^2
STANDARD_DEVIATION 5.4 • n=27 Participants
|
|
Diabetes
Patients with diabetes
|
117 participants
n=93 Participants
|
100 participants
n=4 Participants
|
217 participants
n=27 Participants
|
|
Diabetes
Patients without diabetes
|
119 participants
n=93 Participants
|
138 participants
n=4 Participants
|
257 participants
n=27 Participants
|
|
Hypercholesterolemia
Patients with hypercholesterolemia
|
180 participants
n=93 Participants
|
166 participants
n=4 Participants
|
346 participants
n=27 Participants
|
|
Hypercholesterolemia
Patients without hypercholesterolemia
|
56 participants
n=93 Participants
|
72 participants
n=4 Participants
|
128 participants
n=27 Participants
|
|
Hypertension
Patients with hypertension
|
210 participants
n=93 Participants
|
194 participants
n=4 Participants
|
404 participants
n=27 Participants
|
|
Hypertension
Patients without hypertension
|
26 participants
n=93 Participants
|
44 participants
n=4 Participants
|
70 participants
n=27 Participants
|
|
Smoking status
Never smoked
|
32 participants
n=93 Participants
|
37 participants
n=4 Participants
|
69 participants
n=27 Participants
|
|
Smoking status
Quit
|
131 participants
n=93 Participants
|
123 participants
n=4 Participants
|
254 participants
n=27 Participants
|
|
Smoking status
Still smokes
|
73 participants
n=93 Participants
|
77 participants
n=4 Participants
|
150 participants
n=27 Participants
|
|
Smoking status
Unknown
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Stenosed lesion length
|
54.6 mm
STANDARD_DEVIATION 40.7 • n=93 Participants
|
53.2 mm
STANDARD_DEVIATION 40.3 • n=4 Participants
|
53.9 mm
STANDARD_DEVIATION 40.5 • n=27 Participants
|
|
Normal-to-normal Lesion length
|
66.4 mm
STANDARD_DEVIATION 38.9 • n=93 Participants
|
63.2 mm
STANDARD_DEVIATION 40.5 • n=4 Participants
|
64.8 mm
STANDARD_DEVIATION 39.7 • n=27 Participants
|
|
Percent diameter stenosis
|
79.8 percent of proximal ref. vessel diameter
STANDARD_DEVIATION 17 • n=93 Participants
|
78.4 percent of proximal ref. vessel diameter
STANDARD_DEVIATION 17.1 • n=4 Participants
|
79.1 percent of proximal ref. vessel diameter
STANDARD_DEVIATION 17 • n=27 Participants
|
|
Total Occlusion
Lesions with total occlusion
|
79 lesions
n=93 Participants
|
68 lesions
n=4 Participants
|
147 lesions
n=27 Participants
|
|
Total Occlusion
Lesions without total occlusion
|
162 lesions
n=93 Participants
|
180 lesions
n=4 Participants
|
342 lesions
n=27 Participants
|
|
Calcification
None
|
4 lesions
n=93 Participants
|
12 lesions
n=4 Participants
|
16 lesions
n=27 Participants
|
|
Calcification
Little
|
62 lesions
n=93 Participants
|
95 lesions
n=4 Participants
|
157 lesions
n=27 Participants
|
|
Calcification
Moderate
|
85 lesions
n=93 Participants
|
55 lesions
n=4 Participants
|
140 lesions
n=27 Participants
|
|
Calcification
Severe
|
90 lesions
n=93 Participants
|
87 lesions
n=4 Participants
|
177 lesions
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 monthsEvent-free survival is defined as freedom from the major adverse events of death, target lesion revascularization, target limb ischemia requiring surgical intervention (bypass or amputation of toe, foot or leg), surgical repair of the target vessel (e.g., dissection requiring surgery), and from worsening of the Rutherford classification by 2 classes or to class 5 or 6. Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and Event-free survival is based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
Outcome measures
| Measure |
Zilver PTX
n=235 Participants
Zilver® PTX™ Drug Eluting Vascular Stent
|
PTA (Control)
n=236 Participants
Percutaneous balloon angioplasty
|
|---|---|---|
|
Event-free Survival Rate
|
90.4 Percentage of participants
|
83.9 Percentage of participants
|
PRIMARY outcome
Timeframe: 12 monthsPrimary patency is defined as a Peak systolic velocity (PSV) ratio \< 2.0 or angiographic percent diameter stenosis \< 50%.
Outcome measures
| Measure |
Zilver PTX
n=246 Lesions
Zilver® PTX™ Drug Eluting Vascular Stent
|
PTA (Control)
n=251 Lesions
Percutaneous balloon angioplasty
|
|---|---|---|
|
Primary Patency
|
82.7 Percentage of participants
|
32.7 Percentage of participants
|
Adverse Events
Zilver PTX
Serious events: 21 serious events
Other events: 81 other events
Deaths: 0 deaths
PTA (Control)
Serious events: 37 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zilver PTX
n=235 participants at risk
Zilver® PTX™ Drug Eluting Vascular Stent
|
PTA (Control)
n=236 participants at risk
Percutaneous balloon angioplasty
|
|---|---|---|
|
Vascular disorders
Clinically-driven TLR (Target Lesion Revascularization)
|
8.9%
21/235 • Number of events 21 • 12 months
Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and adverse events are based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
|
15.3%
36/236 • Number of events 36 • 12 months
Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and adverse events are based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
|
|
Vascular disorders
Worsening of Rutherford classification by 2 classes or to a class 5 or 6
|
0.00%
0/235 • 12 months
Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and adverse events are based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
|
0.85%
2/236 • Number of events 2 • 12 months
Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and adverse events are based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
|
|
Surgical and medical procedures
Amputation
|
0.43%
1/235 • Number of events 1 • 12 months
Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and adverse events are based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
|
0.00%
0/236 • 12 months
Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and adverse events are based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
|
Other adverse events
| Measure |
Zilver PTX
n=235 participants at risk
Zilver® PTX™ Drug Eluting Vascular Stent
|
PTA (Control)
n=236 participants at risk
Percutaneous balloon angioplasty
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia requiring antibiotics
|
5.1%
12/235 • Number of events 14 • 12 months
Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and adverse events are based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
|
2.1%
5/236 • Number of events 6 • 12 months
Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and adverse events are based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
|
|
Vascular disorders
Post-procedure percutaneous intervention (e.g., PTA and/or stent) to the study vessel
|
5.5%
13/235 • Number of events 14 • 12 months
Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and adverse events are based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
|
8.1%
19/236 • Number of events 22 • 12 months
Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and adverse events are based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
|
|
Vascular disorders
Post-procedure percutaneous intervention (e.g., PTA and/or stent) to another vessel
|
21.3%
50/235 • Number of events 62 • 12 months
Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and adverse events are based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
|
16.9%
40/236 • Number of events 52 • 12 months
Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and adverse events are based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
|
|
Vascular disorders
Worsened claudication/rest pain
|
4.3%
10/235 • Number of events 12 • 12 months
Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and adverse events are based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
|
6.8%
16/236 • Number of events 21 • 12 months
Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and adverse events are based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
|
|
Vascular disorders
Post-procedure transfusion
|
5.5%
13/235 • Number of events 13 • 12 months
Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and adverse events are based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
|
4.2%
10/236 • Number of events 15 • 12 months
Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and adverse events are based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
|
Additional Information
Scott Snyder, PhD, Director of Clinical Science and Biostatistics
Cook
Phone: 765-463-7537
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60