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Clinical Trials/NCT02066740
NCT02066740
Completed
Not Applicable

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

Medtronic Endovascular1 site in 1 country34 target enrollmentFebruary 2014
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ConditionsPeripheral Arterial Diseases

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Arterial Diseases
Sponsor
Medtronic Endovascular
Enrollment
34
Locations
1
Primary Endpoint
Absence of Stent Elongation
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
July 2014
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Medtronic Endovascular
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Absence of Stent Elongation

Time Frame: Intra operative

Absence of stent elongation is achieved when the implanted stent length does not exceed the allowed stent length

Successful Stent Deployment

Time Frame: Procedure

Successful stent deployment to be assessed based on stent delivery, lesion coverage and accuracy of deployment.

Study Sites (1)

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