Trial Outcomes & Findings for Zilver PTX Drug-Eluting Peripheral Stent Study (NCT NCT01348425)

NCT ID: NCT01348425

Last Updated: 2016-02-02

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment)
• Results posted on: 2016-02-02

Participant Flow

Participant milestones

Measure	Longer Stents Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent	Shorter Stents Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only
Overall Study STARTED	31	14
Overall Study COMPLETED	30	13
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Longer Stents Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent	Shorter Stents Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only
Overall Study Imaging was not taken.	1	1

Baseline Characteristics

Zilver PTX Drug-Eluting Peripheral Stent Study

Baseline characteristics by cohort

Measure	Longer Stents n=31 Participants Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent	Shorter Stents n=14 Participants Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only	Total n=45 Participants Total of all reporting groups
Age, Continuous	67.6 years STANDARD_DEVIATION 9.2 • n=5 Participants	71.6 years STANDARD_DEVIATION 8.3 • n=7 Participants	68.8 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	9 Participants n=7 Participants	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment)

Outcome measures

Measure	Longer Stents n=30 Participants Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent	Shorter Stents n=13 Participants Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only
Percent Change in Stent Length Upon Deployment	0.5 Change in stent length (%) Standard Deviation 4.2	-0.2 Change in stent length (%) Standard Deviation 3.8

Adverse Events

Stented Patients

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Stented Patients n=45 participants at risk The adverse events were combined because all patients were treated with Zilver PTX stents. The safety of Zilver PTX has been previously established and the primary objective of this study was changes in post-deployment stent length; i.e. immediately post-procedure.
Renal and urinary disorders Renal disease	2.2% 1/45 • Number of events 1 • 30 days
Respiratory, thoracic and mediastinal disorders Pulmonary disease	2.2% 1/45 • Number of events 1 • 30 days
Surgical and medical procedures Orthopedic/vascular repair	2.2% 1/45 • Number of events 1 • 30 days
Vascular disorders Restenosis/occlusion of study lesion	2.2% 1/45 • Number of events 1 • 30 days
Vascular disorders Restenosis/occlusion of non-study limb	2.2% 1/45 • Number of events 1 • 30 days

Other adverse events

Adverse event data not reported

Additional Information

Scott Snyder, PhD, Director of Clinical Science and Biostatistics

Cook

Phone: 765-463-7537

Email: ssnyder@medinst.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60