Zilver PTX Delivery System

Peripheral Vascular Disease Clinical Trial

Official title:

Zilver Paclitaxel(PTX) Thumbwheel Delivery System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271529
• Other study ID #: 13-14
• Status: Completed
• Phase: N/A
• First received: October 17, 2014
• Last updated: January 29, 2016
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: January 2016
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries

• Patient has atherosclerotic lesion of the above-the-knee femoropopliteal artery

Exclusion Criteria:

• Patient is < 18 years of age

• Patient unable to complete required follow-up assessments

• Patient unwilling to sign and date the informed consent

• Simultaneous participation in another investigational drug or device study

• Pregnant, breastfeeding or planning to become pregnant in the next 5 years

• Additional medical/anatomical restrictions as specified in the Clinical Investigation Plan

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• Zilver® PTX® Drug-Eluting Peripheral Stent
Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.

Locations

Country	Name	City	State
Australia	Frankston Hospital	Frankston
Australia	Princess Alexandra Hospital	Woolloongabba
Germany	Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH	Bad Krozingen
New Zealand	Auckland City Hospital	Auckland
New Zealand	Waikato Hospital	Hamilton
New Zealand	Wellington Hospital	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Countries where clinical trial is conducted

Australia,  Germany,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Change in Stent Length Upon Deployment		Immediately following completion of the stent placement procedure	No