Trial Outcomes & Findings for Malignant Obstruction ZILVER Against Routine Therapy (MOZART I) (NCT NCT00196105)
NCT ID: NCT00196105
Last Updated: 2011-10-03
Results Overview
Number of days of stent patency: The time to stent occlusion requiring re-intervention, death, loss to follow-up, or patients alive at study end without an occlusion (\>= 6 months after placement).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
241 participants
Primary outcome timeframe
up to 32 months
Results posted on
2011-10-03
Participant Flow
Participant milestones
| Measure |
6 mm Zilver
6 mm Nitinol Zilver Stent
|
10 mm Zilver
10 mm Nitinol Zilver Stent
|
10 mm Wallstent
10 mm Stainless Steel Wallstent
|
|---|---|---|---|
|
Overall Study
STARTED
|
64
|
88
|
89
|
|
Overall Study
COMPLETED
|
60
|
83
|
82
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
7
|
Reasons for withdrawal
| Measure |
6 mm Zilver
6 mm Nitinol Zilver Stent
|
10 mm Zilver
10 mm Nitinol Zilver Stent
|
10 mm Wallstent
10 mm Stainless Steel Wallstent
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
7
|
Baseline Characteristics
Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)
Baseline characteristics by cohort
| Measure |
6 mm Zilver
n=64 Participants
6 mm Nitinol Zilver Stent
|
10 mm Zilver
n=88 Participants
10 mm Nitinol Zilver Stent
|
10 mm Wallstent
n=89 Participants
10 mm Stainless Steel Wallstent
|
Total
n=241 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
71.3 Years
n=99 Participants
|
72.8 Years
n=107 Participants
|
71.5 Years
n=206 Participants
|
71.9 Years
n=7 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
115.0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
126.0 Participants
n=7 Participants
|
|
Biliary Sphincterotomy
Patients with Biliary Sphincterotomy
|
39 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
138 Participants
n=7 Participants
|
|
Biliary Sphincterotomy
Patients without Biliary Sphincterotomy
|
25 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
103 Participants
n=7 Participants
|
|
Previous Plastic Stent
Patients with Previous Plastic Stent
|
32 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
114 Participants
n=7 Participants
|
|
Previous Plastic Stent
Patients without Previous Plastic Stent
|
32 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
127 Participants
n=7 Participants
|
|
Tumor Diagnosis
Patients with Pancreatic Cancer
|
48 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
181 Participants
n=7 Participants
|
|
Tumor Diagnosis
Patients with Metastatic Cancer
|
4 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Tumor Diagnosis
Patients with Cholangiocarcinoma
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Tumor Diagnosis
Patients with Gallbladder Cancer
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Tumor Diagnosis
Patients with Other Cancer
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Tumor Diagnosis
Patients without Tumor
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Bilirubin
|
9.6 mg/dL
STANDARD_DEVIATION 8.7 • n=99 Participants
|
8.7 mg/dL
STANDARD_DEVIATION 7.3 • n=107 Participants
|
8.3 mg/dL
STANDARD_DEVIATION 8.7 • n=206 Participants
|
8.8 mg/dL
STANDARD_DEVIATION 8.2 • n=7 Participants
|
|
Karnofsky Index
|
80.5 Units on a Scale
STANDARD_DEVIATION 9.5 • n=99 Participants
|
80.6 Units on a Scale
STANDARD_DEVIATION 9.9 • n=107 Participants
|
81.2 Units on a Scale
STANDARD_DEVIATION 9.2 • n=206 Participants
|
80.8 Units on a Scale
STANDARD_DEVIATION 9.5 • n=7 Participants
|
PRIMARY outcome
Timeframe: up to 32 monthsNumber of days of stent patency: The time to stent occlusion requiring re-intervention, death, loss to follow-up, or patients alive at study end without an occlusion (\>= 6 months after placement).
Outcome measures
| Measure |
6 mm Zilver
n=64 Participants
6 mm Nitinol Zilver Stent
|
10 mm Zilver
n=88 Participants
10 mm Nitinol Zilver Stent
|
10 mm Wallstent
n=89 Participants
10 mm Stainless Steel Wallstent
|
|---|---|---|---|
|
Patency
|
110 Days
Interval 7.0 to 595.0
|
125.5 Days
Interval 5.0 to 671.0
|
121 Days
Interval 0.0 to 961.0
|
PRIMARY outcome
Timeframe: up to 32 monthsBiliary stents may become closed or blocked. This is also termed "Occlusion." Data for this outcome measure involve stent occlusions that required re-intervention.
Outcome measures
| Measure |
6 mm Zilver
n=64 Participants
6 mm Nitinol Zilver Stent
|
10 mm Zilver
n=88 Participants
10 mm Nitinol Zilver Stent
|
10 mm Wallstent
n=89 Participants
10 mm Stainless Steel Wallstent
|
|---|---|---|---|
|
Closure or Blockage of the Stent (Occlusion)
|
25 Stent Occlusions
|
21 Stent Occlusions
|
19 Stent Occlusions
|
PRIMARY outcome
Timeframe: up to 32 monthsOutcome measures
| Measure |
6 mm Zilver
n=25 Participants
6 mm Nitinol Zilver Stent
|
10 mm Zilver
n=21 Participants
10 mm Nitinol Zilver Stent
|
10 mm Wallstent
n=19 Participants
10 mm Stainless Steel Wallstent
|
|---|---|---|---|
|
Number of Days to Occlusion
|
115 Days
Interval 7.0 to 595.0
|
111 Days
Interval 6.0 to 506.0
|
103 Days
Interval 7.0 to 386.0
|
PRIMARY outcome
Timeframe: up to 32 monthsOutcome measures
| Measure |
6 mm Zilver
n=64 Participants
6 mm Nitinol Zilver Stent
|
10 mm Zilver
n=88 Participants
10 mm Nitinol Zilver Stent
|
10 mm Wallstent
n=89 Participants
10 mm Stainless Steel Wallstent
|
|---|---|---|---|
|
Number of Deaths
|
4 Participants
|
6 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: up to 32 monthsOverall Survival
Outcome measures
| Measure |
6 mm Zilver
n=64 Participants
6 mm Nitinol Zilver Stent
|
10 mm Zilver
n=88 Participants
10 mm Nitinol Zilver Stent
|
10 mm Wallstent
n=89 Participants
10 mm Stainless Steel Wallstent
|
|---|---|---|---|
|
Time to Death
|
132.6 Days
Interval 74.0 to 328.0
|
186 Days
Interval 92.0 to 304.0
|
170 Days
Interval 99.0 to 273.0
|
Adverse Events
6 mm Zilver
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
10 mm Zilver
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
10 mm Wallstent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60