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NCT02066740 Clinical Trial

EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study

Peripheral Arterial Diseases Clinical Trial

Official title:
EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02066740
Other study ID # CP1007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2014
Est. completion date July 2014

Study information
Verified date February 2019
Source Medtronic Endovascular
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to collect acute confirmatory data to evaluate technical success and acute safety of the EverFlex™ self-expanding peripheral stent with Entrust™ delivery system.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Has stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts),

- or occluded lesion(s) located in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) suitable for primary stenting.

Exclusion Criteria:

- Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• EverFlex™ stent with Entrust™ delivery system

Locations
Country Name City State
Germany Klinikum Weiden Weiden

Sponsors (1)
Lead Sponsor Collaborator
Medtronic Endovascular

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Absence of Stent Elongation Absence of stent elongation is achieved when the implanted stent length does not exceed the allowed stent length Intra operative
Primary Successful Stent Deployment Successful stent deployment to be assessed based on stent delivery, lesion coverage and accuracy of deployment. Procedure
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