Trial Outcomes & Findings for Zilver PTX Delivery System (NCT NCT02271529)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Immediately following completion of the stent placement procedure

Results posted on

2016-02-26

Participant milestones
Measure	Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
Overall Study STARTED	40
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
Overall Study Withdrawal by Subject	1

Zilver PTX Delivery System

Baseline characteristics by cohort
Measure	Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent n=40 Participants Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
Age, Continuous	67 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants

Timeframe: 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.

Outcome measures
Measure	Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent n=61 Stents Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
Mean Percent Change in Stent Length Upon Deployment	-1.0 percentage of change in stent length Standard Deviation 2.1

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent n=40 participants at risk Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
Injury, poisoning and procedural complications Hematoma	2.5% 1/40 • Number of events 1 • 1 month
Injury, poisoning and procedural complications Pseudoaneurysm	2.5% 1/40 • Number of events 1 • 1 month
Vascular disorders Thrombosis	2.5% 1/40 • Number of events 1 • 1 month
Vascular disorders Vascular injury requiring intervention	2.5% 1/40 • Number of events 1 • 1 month
Gastrointestinal disorders Extensive metastatic disease of the abdomen and pelvis	2.5% 1/40 • Number of events 1 • 1 month
Injury, poisoning and procedural complications Ooze from left groin access site	2.5% 1/40 • Number of events 1 • 1 month

Adverse event data not reported

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Phone: 765-463-7537

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